Actively Recruiting
Impact of Chronic Renal Failure on Plasma Exposure 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
220 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
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
Official Title
Impact of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors in Patients Treated for Metastatic Kidney Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient followed for metastatic clear cell renal cell carcinoma.
- Age 18 years or older.
- 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.
- Patients grouped by kidney function: normal renal function (group 1), moderate chronic renal failure (stage 3, Clr <60 ml/min, group 2), or severe/terminal chronic renal failure (stage 4 or 5, Clr <30 ml/min, 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.
You will not qualify if you...
- 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.
AI-Screening
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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
Research Team
A
Aurore MOUSSION
CONTACT
E
Emmanuelle TEXIER
CONTACT
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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