An Open-Label, Multi-Center, Phase 2 Safety and Efficacy Study of Denosumab (AMG 162) in Subjects With Recurrent or Unresectable Giant Cell Tumor (GCT) of Bone
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
GCT, Giant Cell Tumor of Bone
Both
GCT, Giant Cell Tumor of Bone
Trial Information
An Open-Label, Multi-Center, Phase 2 Safety and Efficacy Study of Denosumab (AMG 162) in Subjects With Recurrent or Unresectable Giant Cell Tumor (GCT) of Bone
Inclusion Criteria:
- Adults, 18 years and older
- Histologically confirmed and measurable giant cell tumor
- Recurrent GCT confirmed by radiology or unresectable GCT
- ECOG performance status of 0, 1 or 2
Exclusion Criteria:
- Subjects 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Australia: Therapeutic Goods Administration
Study ID:
20040215
NCT ID:
NCT00396279
Start Date:
July 2006
Completion Date:
February 2011
Related Keywords:
- GCT
- Giant Cell Tumor of Bone
- Giant Cell Tumor of Bone
- Bone Neoplasms
- Giant Cell Tumors
- Giant Cell Tumor of Bone
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