CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 535 enrolled
Drug / intervention
Denosumabdrug
Likely dose
Denosumab 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00680992
NCT00680992Phase 2Completed
CompareCT.gov

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

Amgen·interventional·Posted May 20, 2008·Updated Sep 22, 2022

In Brief

A Phase 2 clinical trial evaluating Denosumab for Cancer and 3 related conditions. Completed, enrolled 535 participants across 33 sites in 12 countries.

Detailed Summary

To determine how safe denosumab is in treating subjects with giant cell tumor of bone (GCTB)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer, Giant Cell Tumors, Giant Cell Tumor of Bone, Benign Giant Cell Tumors
CountriesAustralia, Austria, Canada, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 20, 2008
Enrollment StartSep 9, 2008
Primary CompletionMay 17, 2018
TodayJul 2, 2026
Enrollment to primary: 9.7 yearsPosted 18.1 years ago

Interventions

Denosumabdrug

120 mg administered subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study days 8 and 15.