EUCTR2006-000339-93-IT进行中（未招募）不适用
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid Zometa in the Treatment of Bone Metastases in Subjects with Advanced Breast Cancer - ND
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 1,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •61623; adult man or woman with histologically or cytologically confirmed breast adenocarcinoma 61623; current or prior radiographic x-ray, magnetic resonance imaging MRI or computer tomography CT evidence of at least 1 bone metastasis 61623; life expectancy 6 months 61623; Eastern Cooperative Oncology Group ECOG performance status of 0, 1, or 2 61623; adequate organ function as defined by the following criteria - serum aspartate aminotransferase AST 61603; 5 x upper limit of normal ULN - serum alanine aminotransferase ALT 61603; 5 x ULN - serum total bilirubin 61603; 2 x ULN - creatinine clearance Cockroft-Gault 61619; 30 mL/min - albumin-adjusted serum calcium 61619; 2.0 mmol/L 8.0 mg/dL and 61603; 2.9 mmol/L 11.5 mg/dL 61623; before any study-specific procedure, 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
排除标准
- •61623; current or prior IV bisphosphonate administration 61623; current or prior oral bisphosphonate treatment for bone metastasis 61623; prior administration of OPG construct ie, AMGN-0007, Fc-OPG or denosumab 61623; known brain metastases 61623; known impending fracture, defined as evidence of osteolytic lesions with cortical bone destruction exceeding 50 in the femur 61623; prior history or current evidence of osteonecrosis/osteomyelitis of the jaw 61623; active dental or jaw condition that requires oral surgery 61623; non-healed dental/oral surgery 61623; planned invasive dental procedure for the course of the study 61623; evidence of any of the following conditions per subject self report or medical chart review - subjects with prior malignancies except breast cancer, basal cell carcinoma or in situ cervical cancer may be enrolled if disease free for 61619; 3 years - unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization - major surgery including surgery to bone , or significant traumatic injury occurring within 4 weeks before randomization - known infection with human immunodeficiency virus - active infection with Hepatitis B virus or Hepatitis C virus 61623; any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results 61623; thirty days or less since receiving an unapproved ie, no marketing authorization has been granted in that country product or device in another clinical trial 61623; subjects must be surgically sterile, postmenopausal, or must agree to use effective contraception during the period of therapy. Female subjects with reproductive potential must have a negative pregnancy test serum or urine within 7 days before randomization. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate 61623; known sensitivity to any of the products to be administered during the study eg, zoledronic acid, mammalian derived products, calcium or vitamin D
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