Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell T… (NCT04586660) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone
China36 participantsStarted 2023-08-17
Plain-language summary
The study aims to evaluate the efficacy of XGEVA® in Chinese participants with giant cell tumor of bone (GCTB).
Who can participate
Age range12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Chinese male or female adults aged ≥ 18 years or skeletally mature adolescents (ie, radiographic evidence of at least 1 mature long bone \[eg, humerus with closed growth epiphyseal plate\]) ≥ 12 years of age.
* Skeletally mature adolescents must weigh at least 45 kg.
* Pathologically confirmed giant cell tumor of bone (GCTB) within 1 year before study enrollment (central pathology review).
* Measurable evidence of active disease within 1 year before study enrollment.
* Participants with surgically unsalvageable disease (eg, sacral, spinal GCTB, or multiple lesions including pulmonary metastases) OR participants whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity.
* Eastern Cooperative Oncology Group performance status (\[ECOG PS\] of ≤ 2).
Exclusion Criteria:
* Known or suspected current diagnosis of underlying malignancy including high-grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma.
* Known diagnosis of malignancy derived from non-musculoskeletal system within the past 5 years (participants with definitively treated basal cell carcinoma and cervical carcinoma in situ are permitted).
* Known or suspected current diagnosis of brown cell tumor of bone or Paget's disease.
* Known or suspected current diagnosis of non GCTB giant cell-rich tumors…