NCT02570789终止4 期
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
Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Treatment assessment by using RECIST 1.1 and adverse events will be documented using the NCI-CTC coding system (version 4.0)
研究概览
简要总结
The purpose of this study is to assess whether certain metabonomics and/or lipidomics features in correlation with pharmacokinetics before, during and after treatment with sunitinib or pazopanib in first line can predict toxicity and efficacy of sunitinib or pazopanib in metastatic clear cell renal cell carcinoma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Woman or man ≥ 18 Years old, histologically proven metastatic clear cell (or al least clear cell predominant) RCC,
- •Good or intermediate risk according to MSKCC-criteria, 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
排除标准
- •Patients with non-clear cell RCC and/or with sarcomatoid differentiation,
- •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, Patients with uncontrolled arterial hypertension,
- •Patients with uncontrolled hypo- or hyperthyroidism,
- •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,
- •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.
研究组 & 干预措施
patients with sunitinib or pazopanib
Experimental
This will be a non-randomized, proof-of-concept, prospective, longitudinal, multi-center study in patients with metastatic clear cell renal cell carcinoma with good or intermediate risk (based on MSKCC criteria) treated with sunitinib or pazopanib in first line.
干预措施: patients with sunitinib or pazopanib (Drug)
结局指标
主要结局
Treatment assessment by using RECIST 1.1 and adverse events will be documented using the NCI-CTC coding system (version 4.0)
时间窗: up to 3 years
次要结局
- Identifying the level metabolotype and/or lipidomotype of metastatic clear cell renal cell carcinoma patients before starting sunitinib or pazopanib (in comparison with healthy volunteers) on blood and urine samples by biochemistry techniques(up to 5 years)
研究者
研究点 (1)
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