A proof of concept study to evaluate the use of metabonomics and lipidomics in predicting toxicity and efficacy of anti-VEGF therapy in patients with metastatic clear cell renal cell carcinoma. - MetaSun

Cliniques Universitaires Saint Luc0 个研究点目标入组 90 人开始时间: 2012年8月10日最近更新: 2020年10月19日

试验速览

暂无简介。

•- Prior Immunotherapy is allowed
•- Woman or man = 18 Years old
•- Histologically proven metastatic clear cell (or at least clear cell predominant) RCC, sarcomatoid differentiation accepted
•- Subjects falling into conditions for reimbursement of sunitinib or pazopanib in the context of mRCC
•- Measurable disease based on RECIST criteria (version 1.1)
•- Subject has given voluntary written informed consent
•- Subject is in the investigator’s opinion, willing and able to comply with the protocol requirements
•- Subject has an ECOG = 2
•- Subject with a life expectancy = 3 months
•- Concurrent treatment with bisphosphonates and denosumab is allowed however it should have been started before screening of the study. If possible starting new medications between the baseline metabolo- and lipidomotype- and the first metabolo- and lipidomotypeanalysis should be avoided
•- Subjects having recovered from side effects from previous therapies to a grade 1 CTC vs 4.0 criteria
•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 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•- Patients with non-clear cell RCC
•- Patients presenting any other type of cancer disease within 5 years from inclusion into this study in the absence of cervical cancer or basocellular carcinoma
•- Patient had major surgery within 4 weeks before enrolment
•- Patient with myocardial infarction within 6 months prior enrolment or with NHYA class III otr IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
•- Patient has another serious medical condition that could potentially interfere with the completion of study
•- Subject known to be Sero-positive for HIV
•- Subject known to be hepatitis B surface antigen positive or who has an active hepatitis C infection
•- Subject has an active systemic infection requiring treatment
•- Female subject is pregnant or breast feeding
•- Subject enrolled in another clinical trial and/or receiving an investigational agent.

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