ACTRN12622001003763招募中2 期
A multi-centre, open label phase 2 trial investigating the effect of evolocumab in addition to chemotherapy or androgen receptor signalling inhibitor therapy on the circulating lipid profile of men with metastatic castration-resistant prostate cancer
ational Health and Medical Research Council0 个研究点目标入组 30 人开始时间: 2022年7月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •1.Males with mCRPC (as per prostate cancer working group (PCWG3)) AND commencing docetaxel, cabazitaxel, abiraterone or enzalutamide for disease progression
- •2.Age > 18 yrs
- •3.WHO ECOG performance status 0-2
- •4.Histological confirmation of prostate cancer
- •5.Adequate hepatic function with serum total bilirubin > 1.5 x upper limit of normal (ULN) range and ALT and AST > 2.5x upper limit of normal range (or < 5.0 times ULN with documented liver metastases), serum albumin > 25 g/L, and ALP > 5x upper limit of normal range
- •6.Adequate renal function (with calculated creatinine clearance >50 ml/min based on the Cockcroft-Gault method, 24 hour urine or GFR scan) and serum creatinine > 1.5 x upper limit of normal range;
- •7.Demonstrated positivity for high-risk circulating plasma lipid profile on Liquid chromatography–mass spectrometry (LCMS)
- •8.Willing and able to comply with all study requirements, including treatment and biospecimen collection
- •9.Signed written informed consent
排除标准
- •1.Known hypersensitivity to evolocumab or its excipients
- •2.Prior myopathy with a lipid lowering agent
- •3.Active hepatic disease, including chronic active hepatitis B or hepatitis C. Testing for these is not mandatory unless clinically indicated.
- •4.Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
研究者
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