NCT04823923 Impact of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors in Patients Treated for Metastatic Kidney Cancer
| NCT ID | NCT04823923 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle |
| Condition | Kidney Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-12-06 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2021-12-06 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 and toxicity in patients with metastatic kidney cancer.
Eligibility Criteria
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.
Contact & Investigator
Fanny LEENHARDT, Dr
PRINCIPAL INVESTIGATOR
Institut du Cancer de Montpellier (ICM)
Frequently Asked Questions
Who can join the NCT04823923 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04823923 currently recruiting?
Yes, NCT04823923 is actively recruiting participants. Contact the research team at DRCI-icm105@icm.unicancer.fr for enrollment information.
Where is the NCT04823923 trial being conducted?
This trial is being conducted at Marseille, France, Montpellier, France, Montpellier, France, Nîmes, France and 1 additional location.
Who is sponsoring the NCT04823923 clinical trial?
NCT04823923 is sponsored by Institut du Cancer de Montpellier - Val d'Aurelle. The principal investigator is Fanny LEENHARDT, Dr at Institut du Cancer de Montpellier (ICM). The trial plans to enroll 60 participants.
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