EUCTR2006-000339-93-BE进行中（未招募）1 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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 2,049
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 (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 0, 1, or 2.
- •- Adequate organ function as defined by the following criteria:
- •1. Serum aspartate aminotransferase (AST) less than or equal to 5 x upper limit of normal (ULN).
- •2. Serum alanine aminotransferase (ALT) less than or equal to 5 x ULN.
- •3. Serum total bilirubin less than or equal to 2 x ULN.
- •4. Creatinine clearance greater than or equal to 30 mL/min.
- •5. Albumin-adjusted serum calcium greater than or equal to 2.0 mmol/L (8.0 mg/dL) and less than or equal to 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, 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 1506
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 543
排除标准
- •- Current or prior IV bisphosphonate administration.
- •- Current or prior oral bisphosphonate treatment for 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 which requires oral surgery.
- •- Non-healed dental/oral surgery.
- •- Planned invasive dental procedure for the course of the study.
- •- Evidence of any of the following conditions per subject self report or medical chart review:
- •1. Any prior malignancy (other than breast cancer, basal cell carcinoma, or in situ cervical cancer) with active disease within 3 years before randomization.
- •2. Known infection with human immunodeficiency virus.
- •3. 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) 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 dosing (eg, zoledronic acid, mammalian derived products, calcium or vitamin D).
研究者
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