Clinical trial · Interventional
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
NCT04823923CI-TRIAL-00085830IREKIrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Neoplasm | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood sampling for ITK dosage | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- OTHER
- label
- Patients without renal insufficiency under pazopanib
- description
- Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription.
- interventionNames
- Other: blood sampling for ITK dosage
- type
- OTHER
- label
- Patients without renal insufficiency under cabozantinib
- description
- Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription.
- interventionNames
- Other: blood sampling for ITK dosage
- type
- OTHER
- label
- Patients with moderate renal impairment under pazopanib
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDvan 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. PMID 19733976
- BACKGROUNDHendrayana 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. PMID 28264440
- BACKGROUNDVerheijen 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. PMID 27470967
- BACKGROUNDLacy 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. PMID 29687244