An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects with Giant Cell Tumor of Bone.--------------------------------------------------------Estudio Fase 2, Multicéntrico, Abierto de Denosumab en sujetos con Tumor Óseo de Células Gigantes

Amgen Ltd0 个研究点目标入组 100 人开始时间: 2008年9月11日最近更新: 2018年6月5日

试验速览

暂无简介。

•- Pathologically confirmed giant cell tumor of bone within 1 year before study enrollment
•- Measurable evidence of active disease within 1 year before study enrollment
•- Subjects with surgically unsalvageable disease (eg, sacral, spinal GCT, or multiple lesions including pulmonary metastases) OR subjects whose planned initial surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity, other than curettage with complete resection of tumor
•- Karnofsky performance status ? 50% (ie, ECOG status 0, 1, or 2)
•- 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) yes
•F.1.3.1 Number of subjects for this age range

•- Currently receiving other GCT specific treatment (eg, radiation, chemotherapy, or embolization)
•- Concurrent bisphosphonate treatment
•- Known or suspected current diagnosis of underlying malignancy including high-grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma
•- Known or suspected current diagnosis of non GCT giant cell-rich tumors
•- Known or suspected current diagnosis of brown cell tumor of bone
•- Known diagnosis of second malignancy within the past 5 years
•- Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
•- Active dental or jaw condition which requires oral surgery
•- Non-healed dental/oral surgery
•- Planned invasive dental procedure for the course of the study
•- Women or men unwilling to use adequate contraceptive measures
•- Thirty days or less since receiving an investigational product
•- Subject has known sensitivity to any of the products to be administered during dosing
•- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures

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