NCT04823923
Impact of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors in Patients Treated for Metastatic Kidney Cancer
Recruiting · Not Applicable · Institut du Cancer de Montpellier - Val d'Aurelle · registry updated 2025-02-12
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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.
Exclusion
- 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.