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Clinical Trials in France / NCT04823923
Recruiting Not applicable

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

NCT04823923 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-12-06
Last updated
2025-02-12

Condition(s) studied

Kidney Neoplasm

Investigational drug(s) / intervention(s)

blood sampling for ITK dosage

blood 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)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patient followed for metastatic clear cell renal cell carcinoma. 2. Age ≥18 years old. 3. Performance Status (PS) according to Eastern Cooperative Oncology Group (ECOG) = 0, 1 or 2 4. Patient treated with a VEGF-R inhibitor: pazopanib or cabozantinib for metastatic kidney cancer. 5. 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. 6. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 7. Patient having given informed, written and express consent. 8. Affiliation to the French Social Security System. Exclusion Criteria: 1. Indication other than clear cell renal cell carcinoma for these same ITKs 2. Pregnant or breast-feeding subjects 3. Patient whose regular follow-up is impossible for psychological, family, social or geographic reasons, 4. Patient under guardianship, curatorship or safeguard of justice 5. Participation in another clinical study with a research product during the last 30 days before inclusion.

Primary outcome measure(s)

Trial sites (5)

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

More Institut du Cancer de Montpellier - Val d'Aurelle trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04823923 on ClinicalTrials.gov ↗ ← All trials in France