EUCTR2006-000848-65-GR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 Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma
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
- 1,690
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
- •-Adult with histologically or cytologically confirmed advanced cancers including solid tumors, multiple myeloma, and lymphoma
- •-Current or prior radiographic (ie, x-ray, computer tomography [CT], or magnetic resonance imaging [MRI]) evidence of at least 1 bone metastasis (or lytic bone lesion from multiple myeloma)
- •-Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •-Adequate organ function as defined by the following criteria:
- •a) serum aspartate aminotransferase (AST) = 5 x upper limit of normal (ULN)
- •b) serum alanine aminotransferase (ALT) = 5 x ULN
- •c) serum total bilirubin = 2 x ULN
- •d) creatinine clearance (Cockroft-Gault, formula included in Section 6.3 of protocol) = 30 mL/min
- •e) albumin-adjusted serum calcium = 2.0 mmol/L (8.0 mg/dL) and = 2.9 mmol/L (11.5 mg/dL). Albumin-adjusted serum calcium, if applicable, will be calculated by the central laboratory.
- •-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
排除标准
- •-Diagnosis of breast or prostate cancer
- •-Current or prior IV bisphosphonate administration
- •-Current or prior oral bisphosphonate for the treatment of bone metastasis / osteolytic lesion
- •-Planned radiation therapy or surgery to bone
- •-Prior administration of denosumab
- •-Known brain metastases
- •-Life expectancy less than 6 months
- •-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 over the course of the study
- •-Evidence of any of the following conditions per subject self report or medical chart review:
- •a) any other prior malignancy (other than basal cell carcinoma, or in situ cervical cancer) with active disease within 3 years before randomization
- •b) known infection with human immunodeficiency virus
- •c)active infection with Hepatitis B or Hepatitis C virus
- •-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
- •-Thirty days or less since receiving an investigational product or device (ie, does not have marketing authorization; thalidomide use is allowed) in another clinical trial
- •-Pregnant or breast-feeding women
- •-Subject with reproductive potential who will not agree to use effective contraception (as defined by the principal investigator or designee)
- •-Known sensitivity to any of the products to be administered during the study (eg, zoledronic acid, mammalian derived products, calcium or vitamin D)
研究者
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