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 个研究点开始时间: 2015年1月9日最近更新: 2015年7月10日

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•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
•F.1.3.1 Number of subjects for this age range 170

•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;

发起方

IRCCS - Istituto di Ricerche Farmacologiche Mario Negri