blood sampling for ITK dosage: Blood sample for ITK dosage at visit 1 (1 month +/- 1 week after the start of treatment) and at visit 2 (3 months +/- 1 month after the start of treatment)
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Residual concentration at equilibrium of ITK in the blood — at 1 month (+/1 week) Assessment in patients treated for metastatic kidney cancer without or with moderate or severe renal impairment if the plasma concentration (residual concentration at equilibrium) of ITK is higher than the target concentration (specific to the ITK molecule : pazopanib : 20 000 ng/mL and cabozantinib : 1000 ng/mL )
Trial sites (5)
Facility
City
Region
Status
APHM Hôpital LA TIMONE
Marseille
France
Recruiting
CHU Montpellier - Hôpital St Eloi
Montpellier
France
Recruiting
ICM Val d'Aurelle
Montpellier
France
Recruiting
CHU de Nîmes, Institut de Cancérologie du Gard
Nîmes
France
Recruiting
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
Toulouse
France
Recruiting
More Institut du Cancer de Montpellier - Val d'Aurelle trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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