Clinical pharmacokinetics of tyrosine kinase inhibitors.
Nielka P van Erp, Hans Gelderblom, Henk-Jan Guchelaar
https://pubmed.ncbi.nlm.nih.gov/19733976Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04823923
Study of the Impact of Chronic Renal Failure Stage on Blood Levels of Kinase Inhibitors in Patients Treated for Metastatic Kidney Cancer
Led by Institut du Cancer de Montpellier - Val d'Aurelle · Updated on 2025-02-12
60
Participants Needed
5
Research Sites
8 weeks
Total Duration
On this page
Sponsors
I
Institut du Cancer de Montpellier - Val d'Aurelle
Lead Sponsor
L
Ligue contre le cancer, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the impact of chronic kidney failure on the blood levels and effects of two kinase inhibitors, pazopanib and cabozantinib, used to treat patients with metastatic kidney cancer. The goal is to understand how kidney function influences the drugs' effectiveness and side effects. This study focuses on patients with normal kidney function or moderate to severe kidney failure, including those on dialysis. Participants take either pazopanib or cabozantinib daily for at least three months as prescribed by their doctors. Blood samples will be collected at one month and three months after starting treatment to measure the concentration of these drugs. These tests are in addition to routine blood tests and will help assess drug levels and tolerance according to kidney function. During the study, patients will attend scheduled visits for blood tests and clinical evaluations to monitor side effects and drug levels. Researchers will analyze blood concentrations and toxicity to propose potential dose adjustments. The primary outcome is measuring the drug concentration in the blood at one month, with additional assessments at three months. The study is sponsored by the Institut du Cancer de Montpellier - Val d'Aurelle and will continue until March 2026.
CONDITIONS
Brief Title
Impact of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors in Patients Treated for Metastatic Kidney Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient followed for metastatic clear cell renal cell carcinoma
- Age 18 years or older
- Performance Status (ECOG) of 0, 1, or 2
- Treated with pazopanib or cabozantinib for metastatic kidney cancer
- Grouped by kidney function: normal, moderate chronic renal failure (CKD-EPI Clr <60 ml/min, stage 3), or severe/terminal chronic renal failure (CKD-EPI Clr <30 ml/min, stage 4 or 5), with or without dialysis
- Willingness and ability to comply with study visits, treatment, and tests
- Provided informed, written consent
- Affiliated to the French Social Security System
You will not qualify if you...
- Indication other than clear cell renal cell carcinoma for pazopanib or cabozantinib
- Pregnant or breastfeeding
- Unable to maintain regular follow-up for psychological, family, social, or geographic reasons
- Under guardianship, curatorship, or legal protection
- Participation in another clinical study with a research product within 30 days before inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Minimum of 3 months
Participants take daily oral kinase inhibitors (pazopanib or cabozantinib) for metastatic kidney cancer according to their medical prescription.
2 visits for blood sampling at 1 month and 3 months after starting treatment
Trial Site Locations
Total: 5 locations
1
APHM Hôpital LA TIMONE
Marseille, France, 13005
Actively Recruiting
2
CHU Montpellier - Hôpital St Eloi
Montpellier, France, 34295
Actively Recruiting
3
ICM Val d'Aurelle
Montpellier, France, 34298
Actively Recruiting
4
CHU de Nîmes, Institut de Cancérologie du Gard
Nîmes, France, 30029
Actively Recruiting
5
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
Toulouse, France, 31059
Actively Recruiting
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Research Team
A
Aurore MOUSSION
E
Emmanuelle TEXIER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
6
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https://pubmed.ncbi.nlm.nih.gov/29687244