Status:
RECRUITING
Impact of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors in Patients Treated for Metastatic Kidney Cancer
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Collaborating Sponsors:
Ligue contre le cancer, France
Conditions:
Kidney Neoplasm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
This study involves patients treated with cabozantinib or pazopanib in their metastatic renal cancer. Indeed, the aim of this study is to assess the blood concentration of these two drugs as well as ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04823923
Start Date
December 6 2021
End Date
March 1 2026
Last Update
February 12 2025
Active Locations (5)
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1
APHM Hôpital LA TIMONE
Marseille, France, 13005
2
CHU Montpellier - Hôpital St Eloi
Montpellier, France, 34295
3
ICM Val d'Aurelle
Montpellier, France, 34298
4
CHU de Nîmes, Institut de Cancérologie du Gard
Nîmes, France, 30029