Kidney Neoplasm Clinical Trial
— IREKIOfficial title:
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
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | March 2026 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | APHM Hôpital LA TIMONE | Marseille | |
France | CHU Montpellier - Hôpital St Eloi | Montpellier | |
France | ICM Val d'Aurelle | Montpellier | |
France | CHU de Nîmes, Institut de Cancérologie du Gard | Nîmes | |
France | Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Institut du Cancer de Montpellier - Val d'Aurelle | Ligue contre le cancer, France |
France,
Hendrayana T, Wilmer A, Kurth V, Schmidt-Wolf IG, Jaehde U. Anticancer Dose Adjustment for Patients with Renal and Hepatic Dysfunction: From Scientific Evidence to Clinical Application. Sci Pharm. 2017 Feb 27;85(1):8. doi: 10.3390/scipharm85010008. — View Citation
Lacy S, Yang B, Nielsen J, Miles D, Nguyen L, Hutmacher M. A population pharmacokinetic model of cabozantinib in healthy volunteers and patients with various cancer types. Cancer Chemother Pharmacol. 2018 Jun;81(6):1071-1082. doi: 10.1007/s00280-018-3581-0. Epub 2018 Apr 23. — View Citation
van Erp NP, Gelderblom H, Guchelaar HJ. Clinical pharmacokinetics of tyrosine kinase inhibitors. Cancer Treat Rev. 2009 Dec;35(8):692-706. doi: 10.1016/j.ctrv.2009.08.004. Epub 2009 Sep 5. — View Citation
Verheijen RB, Bins S, Mathijssen RH, Lolkema MP, van Doorn L, Schellens JH, Beijnen JH, Langenberg MH, Huitema AD, Steeghs N; Dutch Pharmacology Oncology Group. Individualized Pazopanib Dosing: A Prospective Feasibility Study in Cancer Patients. Clin Cancer Res. 2016 Dec 1;22(23):5738-5746. doi: 10.1158/1078-0432.CCR-16-1255. Epub 2016 Jul 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Residual concentration at equilibrium of ITK in the blood | Assessment in patients treated for metastatic kidney cancer without or with moderate or severe renal impairment if the plasma concentration (residual concentration at equilibrium) of ITK is higher than the target concentration (specific to the ITK molecule : pazopanib : 20 000 ng/mL and cabozantinib : 1000 ng/mL ) | at 1 month (+/1 week) | |
Secondary | Concentration of ITK in the blood in patients with Failure renal function | Assessment the plasma concentration (residual concentration at equilibrium) of ITK (pazopanib and / or cabozantinib) in patients with moderate renal impairment and / or severe renal impairment | at 1 month (+/- 1 week) and 3 months (+/- 1 month) | |
Secondary | Concentration of ITK in the blood in patients with normal renal function | Assessment the plasma concentration (residual concentration at equilibrium) of ITK (pazopanib and / or cabozantinib) in patients with normal renal function | at 1 month (+/- 1 week) and 3 months (+/- 1 month) | |
Secondary | Toxicities related to the intake of ITKs | Assessment toxicities induced by the use of ITK targeting Vascular Endothelial Growth Factor-Receptor (VEGF-R) by using the NCI-CTCAE version 5.0 (grade = 2) | at 1 month (+/- 1 week) and 3 months (+/- 1 month) |
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