Recruitment Complete
Sponsor ID
20180119

Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone

Sponsor ID
20180119
Clinicaltrials.gov ID
NCT04586660
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The study aims to evaluate the efficacy of XGEVA® in Chinese participants with giant cell tumor of bone (GCTB).

Additional Study Details

Phase
Phase 4
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
36
Additional Study Details

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
Status
Contact Us
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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