Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Kidney Neoplasms

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Renal Insufficiency, Chronic

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Renal Cell Carcinoma

Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription.

Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription.

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)

blood sampling for ITK dosage

Aurore MOUSSION

Emmanuelle TEXIER

Laurent DEVILLE, Dr

Delphine TOPART, Dr

Fanny LEENHARDT, Dr

Nadine HOUEDE, Pr

Loïc MOUREY, Dr

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.

This study involves patients treated with cabozantinib or pazopanib in their metastatic renal cancer.

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.

Impact of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors in Patients Treated for 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

Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

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 )

Assessment the plasma concentration (residual concentration at equilibrium) of ITK (pazopanib and / or cabozantinib) in patients with moderate renal impairment and / or severe renal impairment

Assessment the plasma concentration (residual concentration at equilibrium) of ITK (pazopanib and / or cabozantinib) in patients with normal renal function

Assessment toxicities induced by the use of ITK targeting Vascular Endothelial Growth Factor-Receptor (VEGF-R) by using the NCI-CTCAE version 5.0 (grade ≥ 2)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Impact of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors in Patients Treated for Metastatic Kidney Cancer	NCT04823923	Kidney Neoplasm	blood sampling ...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Impact of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors in Patients Treated for Metastatic Kidney Cancer	NCT04823923	Kidney Neoplasm	blood sampling ...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle

Spots Global Cancer Trial Database for blood sampling for itk dosage