Status:
COMPLETED
Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone
Lead Sponsor:
Amgen
Conditions:
GCT
Giant Cell Tumor of Bone
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To determine how safe and effective denosumab is in treating patients with giant cell tumor of bone.
Eligibility Criteria
Inclusion
- Adults, 18 years and older
- Histologically confirmed and measurable giant cell tumor (GCT)
- Recurrent GCT confirmed by radiology or unresectable GCT
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion
- Pateints for whom surgery to the affected limb/area is planned within 27 days after receiving 1st dose of denosumab
- Radiation to affected region within 28 days before enrollment to study
- Known diagnosis of osteosarcoma or brown tumor of bone
- Known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ
- Concurrent treatment with bisphosphonates, calcitonin, or interferon.
- Other criteria also apply.
Key Trial Info
Start Date :
July 10 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00396279
Start Date
July 10 2006
End Date
February 1 2011
Last Update
November 8 2022
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