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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 and toxicity in patients with metastatic kidney cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
APHM Hôpital LA TIMONE
RECRUITING
Marseille
CHU Montpellier - Hôpital St Eloi
RECRUITING
Montpellier
ICM Val d'Aurelle
RECRUITING
Montpellier
CHU de Nîmes, Institut de Cancérologie du Gard
RECRUITING
Nîmes
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
RECRUITING
Toulouse
Contact Information
Primary
Aurore MOUSSION
DRCI-icm105@icm.unicancer.fr
04 67 61 31 02
Backup
Emmanuelle TEXIER
DRCI-icm105@icm.unicancer.fr
04 67 61 31 02
Time Frame
Start Date: 2021-12-06
Estimated Completion Date: 2026-03
Participants
Target number of participants: 60
Treatments
Other: Patients without renal insufficiency under pazopanib
Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription.
Other: Patients without renal insufficiency under cabozantinib
Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription.
Other: Patients with moderate renal impairment under pazopanib
Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription.
Other: Patients with moderate renal impairment under cabozantinib
Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription.
Other: Patients with severe or terminal stage renal impairment under pazopanib
Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription.
Other: Patients with severe or terminal stage renal impairment under cabozantinib
Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription.
Sponsors
Collaborators: Ligue contre le cancer, France
Leads: Institut du Cancer de Montpellier - Val d'Aurelle

This content was sourced from clinicaltrials.gov