Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumo… (NCT00396279) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy Study of Denosumab in Patients With Recurrent or Unresectable Giant Cell Tumor of Bone
37 participantsStarted 2006-07-10
Plain-language summary
To determine how safe and effective denosumab is in treating patients with giant cell tumor of bone.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Percentage of Participants With Giant Cell Tumor Response