Impact of kidney function on cancer drug levels in patients with metastatic kidney cancer
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
This study is testing how kidney function affects the levels of cancer drugs in the blood for patients with metastatic kidney cancer to see if they need different doses for better results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle Academic / other |
| Drugs / interventions | cabozantinib |
| Locations | 5 sites (Marseille and 4 other locations) |
| Trial ID | NCT04823923 on ClinicalTrials.gov |
What this trial studies
This study evaluates how chronic renal failure affects the blood concentration of the kinase inhibitors pazopanib and cabozantinib in patients with metastatic kidney cancer. It involves blood sampling at 1 month and 3 months after starting treatment to assess drug efficacy and toxicity based on the patient's renal function. The study aims to determine if dose adjustments are necessary to improve treatment outcomes for patients with varying degrees of renal failure. Regular follow-ups and compliance with treatment are essential for accurate assessment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with metastatic clear cell renal cell carcinoma who are being treated with pazopanib or cabozantinib.
Not a fit: Patients with indications other than clear cell renal cell carcinoma or those who do not meet the renal function criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to optimized dosing of cancer medications for patients with renal impairment, improving their treatment outcomes.
How similar studies have performed: Other studies have explored the effects of renal function on drug metabolism, suggesting that this approach could yield valuable insights, although this specific focus on pazopanib and cabozantinib in metastatic kidney cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Marseille and 4 other locations
- 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)
Study contacts
- Principal investigator: Fanny LEENHARDT, Dr — Institut du Cancer de Montpellier (ICM)
- Study coordinator: Aurore MOUSSION
- Email: DRCI-icm105@icm.unicancer.fr
- Phone: 04 67 61 31 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.