Clinical Trial: Study of Denosumab in Subjects With Giant Cell Tumor of Bone
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Tumor of Bone
Brief Summary: To determine how safe denosumab is in treating subjects with giant cell tumor of bone
Detailed Summary: To determine how safe denosumab is in treating subjects with giant cell tumor of bone
Sponsor: Amgen
Current Primary Outcome: Safety profile of denosumab characterized in terms of the type, frequency, and severity of adverse events and laboratory abnormalities for each cohort. [ Time Frame: Duration of treatment and every 6 months for up to one year post treatment ]
Original Primary Outcome: Safety profile of denosumab characterized in terms of the type, frequency, and severity of adverse events and laboratory abnormalities for each cohort. [ Time Frame: Duration of treatment and 6 months post treatment ]
Current Secondary Outcome:
- Time to disease progression for Cohort 1 [ Time Frame: Interval (in days) from the enrollment date to the date of disease progression ]
- Proportion of subjects without any surgery at month 6 for Cohort 2 [ Time Frame: Six months ]
- Evaluate denosumab pharmacokinetics in adolescent and adult subjects with GCTB (PK subset) [ Time Frame: 25 weeks ]
Original Secondary Outcome: Proportion of subjects able to undergo limb or joint sparing (eg, curettage) surgical procedures [ Time Frame: Six months ]
Information By: Amgen
Dates:
Date Received: May 15, 2008
Date Started: September 2008
Date Completion: November 2017
Last Updated: December 16, 2016
Last Verified: December 2016
