NL-OMON31822已完成3 期
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 - Denosumab 20050136
AMGEN Inc.0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion Criteria:
- •* adult (men included) with histologically or cytologically confirmed breast adenocarcinoma
- •* current or prior radiographic (ie, x-ray, computer tomography [CT], or magnetic resonance imaging [MRI]) evidence of at least 1 bone metastasis
- •* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •* adequate organ function as defined by the following criteria:
- •* serum aspartate aminotransferase (AST) less than or equal to 5 x upper limit of normal (ULN)
- •* serum alanine aminotransferase (ALT) less than or equal to 5 x ULN
- •* serum total bilirubin less than or equal to 2 x ULN
- •* creatinine clearance (Cockcroft-Gault) equal or higher to 30 mL/min
- •* albumin-adjusted serum calcium equal or higher to 2.0 mmol/L (8.0 mg/dL) and less than or equal to 2.9 mmol/L (11.5 mg/dL)
- •* Before any study-specific procedure is performed, the appropriate written informed consent must be obtained.
排除标准
- •Exclusion Criteria:
- •* current or prior IV bisphosphonate administration
- •* current or prior oral bisphosphonate for the treatment of bone metastasis
- •* 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 that 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:
- •* any prior malignancy (other than breast cancer, basal cell carcinoma or in situ cervical cancer) with active disease within 3 years before randomization
- •* known infection with human immunodeficiency virus
- •* active infection with Hepatitis B virus 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) in another clinical trial
- •* 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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