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
- Conditions
- Giant Cell Tumor (GCT) of boneMedDRA version: 9.1Level: LLTClassification code 10005968Term: Bone giant cell tumor
- Registration Number
- EUCTR2006-006964-48-FR
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 34
4.1.1 Adult subjects (=18 years of age) with histologically confirmed giant cell tumor who have measurable (defined as being at least 10 millimeters [mm] in size in the greatest dimension) recurrent GCT confirmed by radiology or unresectable GCT
4.1.2 ECOG performance status of 0, 1, or 2
4.1.3 Before any study- specific procedure is performed, the appropriate written informed consent must be obtained.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
4.2.1 Subjects for whom palliative resection is planned: planned surgical intervention of the affected limb/area 28 days or less after administration of the first dose of denosumab
4.2.2 Radiation to affected region within 28 days before enrollment to study
4.2.3 Known diagnosis of osteosarcoma or brown tumor of bone [osteitis fibrosa cystica])
4.2.4 Known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ
4.2.5 Prior treatment with denosumab
4.2.6 Concurrent treatment with IV or oral bisphosphonates, calcitonin or interferon alpha- 2a
4.2.7 Females of child- bearing potential who are not willing to use adequate contraceptive methods while on study and for 12 months post study, are pregnant (eg, positive urine or serum HCG test), or breast feeding
4.2.8 Men who are not willing to use adequate contraceptive methods while on study and for 12 months post- study
4.2.9 Thirty days or less since receiving an investigational product or device in another clinical study. Current enrollment in another clinical study is not permitted unless the purpose of the study is for long- term follow- up/survival data
4.2.10 Known sensitivity to any of the products to be administered during dosing
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method