EUCTR2014-002508-26-IT
进行中（未招募）
不适用
Outcome-related factors in patients with metastatic renal cell carcinoma treated with everolimus after failure of a first-line treatment with VEGF inhibitor - ORCHIDEE
IRCCS - Istituto di Ricerche Farmacologiche Mario Negri0 个研究点2015年1月9日
相关药物Afinitor
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- IRCCS - Istituto di Ricerche Farmacologiche Mario Negri
- 状态
- 进行中（未招募）
- 最后更新
- 10年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\.Male or female, aged 18 years or older, with histologically or cytologically confirmed mRCC (clear cell or not clear cell);
- •2\.ECOG\-PS \<2;
- •3\.With target and/or non\-target lesions according to RECIST 1\.1;
- •4\.Following failure of a previous treatment with VEGF\-targeted therapy (e.g. sunitinib, sorafenib, pazopanib, or bevacizumab\+interferon);
- •5\.For whom a decision has been taken to initiate everolimus treatment or patient currently receiving treatment with everolimus by a period of time \=30 days;
- •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 30
- •F.1\.3 Elderly (\>\=65 years) yes
排除标准
- •1\.Previous treatment with everolimus or at the date of written informed consent provision receiving everolimus by more than 30 days;
- •2\.Symptomatic central nervous system metastases. Patients may be eligible if the central nervous system
- •metastases have been adequately treated (surgery or radiotherapy), and do not require ongoing
- •corticosteroids for control of symptoms and have had no evidence of progression for at least three months;
- •3\.Treatment with an investigational agent in the past 4 weeks;
- •4\.Any of the following in the last year: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack or pulmonary embolism;
- •5\.Ongoing grade \=2 cardiac dysrhythmias, atrial fibrillation of any grade or prolongation of the corrected QT interval to \>450 msec for males or \>470 msec for females;
- •6\. Pregnancy (negative pregnancy test required for women of child\-bearing potential), breast feeding;
结局指标
主要结局
未指定
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