Giant Cell Tumor (GCT) of bone MedDRA version: 9.1 Level: LLT Classification code 10005968 Term: Bone giant cell tumor
Conditions
Interventions
Product Name: Denosumab
Product Code: AMG 162
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Denosumab
Current Sponsor code: AMG 162
Concentration unit: mg milligram(s)
Concentration
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objectives: To evaluate response to treatment of denosumab in subjects with recurrent or unresectable GCT. Response is defined as: • elimination of giant cells, or doubling of the percentage of apoptotic giant cells, relative to baseline; or, • lack of progression of the largest lesion at week 25 by radiographic measurements ;Secondary Objective: Secondary Objectives: • To measure serum trough levels of denosumab • To evaluate the degree of suppression of bone turnover • To evaluate the safety profile of denosumab • To evaluate the incidence of serum anti- denosumab antibody formation;Primary end point(s): Response rate among evaluable subjects: Response is defined as: For subjects who have tissue samples obtained and measured by histopathology: • elimination of giant cells, or; • doubling of the percentage of apoptotic giant cells relative to baseline, based on the following: - If the baseline ( pre- dose) percentage of apoptotic cells falls between 0 and 25%, then the post- dose percentage of apoptotic cells must be 50% or greater, or; - If the baseline ( pre- dose) percentage of apoptotic cells falls between 26% and 50%, then the post-dose percentage of apoptotic cells must be double relative to the baseline percentage ( ie, between 52% and 100%, respectively), or; - If the baseline ( pre- dose) percentage of apoptotic cells is greater than 50%, then 100% elimination of giant cells must occur. For subjects with both a core biopsy and resected tissue obtained, the sample closest to week 25 will be used in the analysis. For subjects who only have radiographs obtained and no tissue samples: Lack of progression of the largest lesion, defined as no change in the volumetric measurement of the lesion by week 25, compared with baseline. | — |
Countries
France
Outcome results
None listed