Impact of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors in Patients Treated for Metastatic Kidney Cancer
NCT ID: NCT04823923
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2021-12-06
2026-03-31
Brief Summary
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Detailed Description
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Indeed, the aim of this study is to assess the blood concentration of these two drugs as well as their tolerance, in relation to their renal function (normal renal function or moderate or severe renal failure).
Pazopanib and cabozantinib are kinase inhibitors that are indicated for a number of cancer conditions, including metastatic kidney cancer.
Both of these oral therapies require a daily intake of the drug to ensure its effectiveness.
For this, the patient must have optimal compliance and benefit from regular follow up to assess clinical and biological tolerance.
Chronic renal failure is a factor that may impact the efficacy and toxicity of pazopanib and cabozantinib. This may be due either to a elimination default of the drug or to much elimination if the drug is filtered after dialysis.
As a result, kinase inhibitors could be impacted by chronic renal failure and thus modify the safety and efficacy of the treatment.
A study-specific blood test will be taken at 1 month and at 3 months during a consultation (this blood test is in addition to the routine blood test). Its analysis will evaluate the quantity of medication present in the blood.
The other objective of this study is to evaluate the side effects of the drug taken by the patient (pazopanib or cabozantinib).
This will alow to propose possible dose adjustments for each of these treatments and thus improve the management of these patients.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Patients without renal insufficiency under pazopanib
Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription.
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)
Patients without renal insufficiency under cabozantinib
Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription.
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)
Patients with moderate renal impairment under pazopanib
Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription.
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)
Patients with moderate renal impairment under cabozantinib
Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription.
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)
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.
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)
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.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Ligue contre le cancer, France
OTHER
Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
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Principal Investigators
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Fanny LEENHARDT, Dr
Role: PRINCIPAL_INVESTIGATOR
Institut du Cancer de Montpellier (ICM)
Locations
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APHM Hôpital LA TIMONE
Marseille, , France
CHU Montpellier - Hôpital St Eloi
Montpellier, , France
ICM Val d'Aurelle
Montpellier, , France
CHU de Nîmes, Institut de Cancérologie du Gard
Nîmes, , France
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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References
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van Erp NP, Gelderblom H, Guchelaar HJ. Clinical pharmacokinetics of tyrosine kinase inhibitors. Cancer Treat Rev. 2009 Dec;35(8):692-706. doi: 10.1016/j.ctrv.2009.08.004. Epub 2009 Sep 5.
Hendrayana T, Wilmer A, Kurth V, Schmidt-Wolf IG, Jaehde U. Anticancer Dose Adjustment for Patients with Renal and Hepatic Dysfunction: From Scientific Evidence to Clinical Application. Sci Pharm. 2017 Feb 27;85(1):8. doi: 10.3390/scipharm85010008.
Verheijen RB, Bins S, Mathijssen RH, Lolkema MP, van Doorn L, Schellens JH, Beijnen JH, Langenberg MH, Huitema AD, Steeghs N; Dutch Pharmacology Oncology Group. Individualized Pazopanib Dosing: A Prospective Feasibility Study in Cancer Patients. Clin Cancer Res. 2016 Dec 1;22(23):5738-5746. doi: 10.1158/1078-0432.CCR-16-1255. Epub 2016 Jul 28.
Lacy S, Yang B, Nielsen J, Miles D, Nguyen L, Hutmacher M. A population pharmacokinetic model of cabozantinib in healthy volunteers and patients with various cancer types. Cancer Chemother Pharmacol. 2018 Jun;81(6):1071-1082. doi: 10.1007/s00280-018-3581-0. Epub 2018 Apr 23.
Other Identifiers
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2020-A01533-36
Identifier Type: OTHER
Identifier Source: secondary_id
PROICM 2020-08 IRE
Identifier Type: -
Identifier Source: org_study_id
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