Impact of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors in Patients Treated for Metastatic Kidney Cancer (IREKI)
Kidney Neoplasm
About this trial
This is an interventional other trial for Kidney Neoplasm focused on measuring metastatic kidney cancer, pazopanib, cabozantinib, renal failure
Eligibility Criteria
Inclusion Criteria:
- 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 3.
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- APHM Hôpital LA TIMONERecruiting
- CHU Montpellier - Hôpital St EloiRecruiting
- ICM Val d'AurelleRecruiting
- CHU de Nîmes, Institut de Cancérologie du GardRecruiting
- Institut Universitaire du Cancer de Toulouse (IUCT) OncopoleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Other
Other
Other
Other
Other
Other
Patients without renal insufficiency under pazopanib
Patients without renal insufficiency under cabozantinib
Patients with moderate renal impairment under pazopanib
Patients with moderate renal impairment under cabozantinib
Patients with severe or terminal stage renal impairment under pazopanib
Patients with severe or terminal stage renal impairment under cabozantinib
Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription.
Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription.
Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription.
Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription.
Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription.
Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription.