EUCTR2006-000341-19-GB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 Men with Hormone-Refractory Prostate Cancer.
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
- 1,870
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
入选标准
- •-Men greater than or equal to 18 years of age with histologically-confirmed prostate cancer.
- •-Current or prior radiographic (ie, x-ray, computer tomography [CT], or magnetic resonance imaging [MRI]) evidence of at least 1 bone metastasis.
- •-Documented failure of at least one hormonal therapy as evidenced by a rising PSA (ie, 3 consecutive determinations, taken at least 2 weeks apart from one another. The third measurement must be greater than or equal to 0.4 ng/mL and taken within 8 weeks prior to randomization).
- •-Serum testosterone level of < 50 ng/dL due to either surgical or chemical castration
- •-Eastern Cooperative Oncology Group (ECOG) performance status of 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 institutional 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 (Cockcroft-Gault) 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)
- •-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
- •-Current or prior IV bisphosphonate administration for any reason
- •-Current or prior oral bisphosphonate administration for the treatment of bone metastases
- •-Planned radiation therapy or surgery to bone
- •-Prior administration of denosumab
- •-Known brain metastasis
- •-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(s) for the course of the study
- •-Evidence of any of the following conditions per subject self report or medical chart review:
- •1. Known history of second malignancy within the past 3 years, except for basal cell carcinoma
- •2. Known infection with human immunodeficiency virus
- •3. Active infection with hepatitis B or hepatitis C virus
- •-Any 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 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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