RecruitingNot ApplicableNCT04823923

Impact of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors in Patients Treated for Metastatic Kidney Cancer

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

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

60 participants

Start Date

Dec 6, 2021

Study Type

INTERVENTIONAL

Conditions

Kidney Neoplasm

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria5

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.

Interventions

OTHERblood sampling for ITK dosage

Blood sample for ITK dosage at visit 1 (1 month +/- 1 week after the start of treatment) and at visit 2 (3 months +/- 1 month after the start of treatment)