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

Recruiting now · Not applicable

Conditions studied: Kidney Neoplasm

In brief

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.

Key facts

Study ID

NCT04823923

Run by

Institut du Cancer de Montpellier - Val d'Aurelle

People needed

60

Starts

2021-12-06

Expected to finish

2026-03-01

Last updated by the study team

2025-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• APHM Hôpital LA TIMONE — Marseille, France (enrolling)
• CHU Montpellier - Hôpital St Eloi — Montpellier, France (enrolling)
• ICM Val d'Aurelle — Montpellier, France (enrolling)
• CHU de Nîmes, Institut de Cancérologie du Gard — Nîmes, France (enrolling)
• Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole — Toulouse, France (enrolling)

Full record on ClinicalTrials.gov

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