EUCTR2006-000848-65-DE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
适应症
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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