Study of the Impact of the Stage of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors (ITK) in Patients Treated for Metastatic Kidney Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Residual concentration at equilibrium of ITK in the blood
研究概览
简要总结
The study of the blood concentration of ITK what are pazopanib and cabozantinib at 1 month and 3 months from the start of treatment will allow to evaluate the impact of renal failure on their efficacy and toxicity in patients with metastatic kidney cancer.
详细描述
This study involves patients treated with cabozantinib or pazopanib in their metastatic renal cancer.
Indeed, the aim of this study is to assess the blood concentration of these two drugs as well as their tolerance, in relation to their renal function (normal renal function or moderate or severe renal failure).
Pazopanib and cabozantinib are kinase inhibitors that are indicated for a number of cancer conditions, including metastatic kidney cancer.
Both of these oral therapies require a daily intake of the drug to ensure its effectiveness.
For this, the patient must have optimal compliance and benefit from regular follow up to assess clinical and biological tolerance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patient followed for metastatic clear cell renal cell carcinoma.
- •Age ≥18 years old.
- •Performance Status (PS) according to Eastern Cooperative Oncology Group (ECOG) = 0, 1 or 2
- •Patient treated with a VEGF-R inhibitor: pazopanib or cabozantinib for metastatic kidney cancer.
- •If patient doesn't have renal failure -> group 1, or if patient has chronic renal failure according to the moderate stage Chronic Kidney Disease - Epidemiology (CKD-EPI) formula (Clr <60 ml / min, stage 3) -> group 2, or if patient have chronic renal failure according to the CKD-EPI formula of severe or terminal stage (Clr <30 ml / min, stage 4 and stage 5), with or without dialysis -> group
- •Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- •Patient having given informed, written and express consent.
- •Affiliation to the French Social Security System.
排除标准
- •Indication other than clear cell renal cell carcinoma for these same ITKs
- •Pregnant or breast-feeding subjects
- •Patient whose regular follow-up is impossible for psychological, family, social or geographic reasons,
- •Patient under guardianship, curatorship or safeguard of justice
- •Participation in another clinical study with a research product during the last 30 days before inclusion.
研究组 & 干预措施
Patients without renal insufficiency under pazopanib
Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription.
干预措施: blood sampling for ITK dosage (Other)
Patients without renal insufficiency under cabozantinib
Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription.
干预措施: blood sampling for ITK dosage (Other)
Patients with moderate renal impairment under pazopanib
Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription.
干预措施: blood sampling for ITK dosage (Other)
Patients with moderate renal impairment under cabozantinib
Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription.
干预措施: blood sampling for ITK dosage (Other)
Patients with severe or terminal stage renal impairment under pazopanib
Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription.
干预措施: blood sampling for ITK dosage (Other)
Patients with severe or terminal stage renal impairment under cabozantinib
Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription.
干预措施: blood sampling for ITK dosage (Other)
结局指标
主要结局
Residual concentration at equilibrium of ITK in the blood
时间窗: at 1 month (+/1 week)
Assessment in patients treated for metastatic kidney cancer without or with moderate or severe renal impairment if the plasma concentration (residual concentration at equilibrium) of ITK is higher than the target concentration (specific to the ITK molecule : pazopanib : 20 000 ng/mL and cabozantinib : 1000 ng/mL )
次要结局
- Toxicities related to the intake of ITKs(at 1 month (+/- 1 week) and 3 months (+/- 1 month))
- Concentration of ITK in the blood in patients with Failure renal function(at 1 month (+/- 1 week) and 3 months (+/- 1 month))
- Concentration of ITK in the blood in patients with normal renal function(at 1 month (+/- 1 week) and 3 months (+/- 1 month))