The study aims to evaluate the efficacy of XGEVA® in Chinese participants with giant cell tumor of bone (GCTB).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Participants will receive XGEVA® 120 mg subcutaneously (SC) once every 4 weeks (Q4W) with a loading dose of 120 mg SC on day 8 and day 15.
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Objective tumor response
Objective tumor response is defined as the percentage of participants with complete response (CR) or partial response (PR) evaluated based on European Organisation for Research and Treatment of Cancer (EORTC) criteria and Response Evaluation Criteria in Solid Tumors (RECIST).
Time frame: Up to 36 months
Time to disease progression or recurrence in participants with unsalvageable giant cell tumor of bone (GCTM) (Cohort 1 only)
Time frame: 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)
Time frame: Month 36
Time to disease progression or recurrence for participants with complete response (CR) from time of surgery (Cohort 2 only)
Time frame: 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)
Time frame: Up to 36 months
Number of participants with surgically downstaging in participants with salvageable giant cell tumor of bone (GCTB) (Cohort 2 only)
Time frame: Up to 36 months
Change from baseline in bone turnover markers (urinary N-telopeptide [uNTX]/creatinine ratio)
Time frame: Baseline to Month 36
Change from baseline in severity of pain assessed by Brief Pain Inventory - Short Form (BPI-SF) score
Pain severity will be assessed using Brief Pain Inventory - Short Form. The minimum score is 0 (no pain) and the maximum score is 10 (worst pain imaginable). The higher the score means a worse outcome of more pain.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Third Affiliated Hospital Of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Harbin Meidical University Cancer Hospital
Harbin, Heilongjiang, China
Tangdu Hospital of Air Force Medical University
Xi'an, Shaanxi, China
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Time frame: Baseline to Month 36
Number of participants who experience one or more treatment-emergent adverse events (TEAEs)
Time frame: Baseline to end of safety follow-up, up to approximately 37 months
Number of participants who experience adverse events of special interest
Adverse events of special interest include hypocalcemia, hypercalcemia following investigational product discontinuation, atypical femoral fracture, and osteonecrosis of the jaw.
Time frame: Baseline to end of safety follow-up, up to approximately 37 months
Serum XGEVA concentration levels
Time frame: Up to 36 months