Recruitment Complete
Sponsor ID
20180119
Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone
Study Details
The study aims to evaluate the efficacy of XGEVA® in Chinese participants with giant cell tumor of bone (GCTB).
Protocol Summary
Primary Outcome Measures
Objective tumor response
Timeframe: Up to 36 months
Secondary Outcome Measures
Time to disease progression or recurrence in participants with unsalvageable giant cell tumor of bone (GCTM) (Cohort 1 only)
Timeframe: From baseline until end of treatment, up to a maximum of 36 months
Number of participants with surgically salvageable giant cell tumor of bone (GCTB) after treatment (Cohort 1 only)
Timeframe: Month 36
Time to disease progression or recurrence for participants with complete response (CR) from time of surgery (Cohort 2 only)
Timeframe: From time of surgery until end of treatment, up to a maximum of 36 months
Number of participants who do not require surgery in participants with salvageable giant cell tumor of bone (GCTB) (Cohort 2 only)
Timeframe: Up to 36 months
Number of participants with surgically downstaging in participants with salvageable giant cell tumor of bone (GCTB) (Cohort 2 only)
Timeframe: Up to 36 months
Change from baseline in bone turnover markers (urinary N-telopeptide [uNTX]/creatinine ratio)
Timeframe: Baseline to Month 36
Change from baseline in severity of pain assessed by Brief Pain Inventory - Short Form (BPI-SF) score
Timeframe: Baseline to Month 36
Number of participants who experience one or more treatment-emergent adverse events (TEAEs)
Timeframe: Baseline to end of safety follow-up, up to approximately 37 months
Number of participants who experience adverse events of special interest
Timeframe: Baseline to end of safety follow-up, up to approximately 37 months
Serum XGEVA concentration levels
Timeframe: Up to 36 months
Locations
Location
Taipei Veterans General Hospital
Taipei, Taipei, Taiwan, 11217
Status
Recruiting
Location
National Taiwan University Hospital
Taipei, Taipei, Taiwan, 10002
Status
Recruiting
Location
Peking University Peoples Hospital
Beijing, Beijing, China, 100044
Status
Recruiting
Location
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510663
Status
Recruiting
Location
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Status
Recruiting
Location
The Third Affiliated Hospital Of Southern Medical University
Guangzhou, Guangdong, China, 510630
Status
Recruiting
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