blood sampling for ITK dosage
OtherBlood 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)
NCT Number: NCT04823923
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
APHM Hôpital LA TIMONE, Marseille, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: 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 )
Time frame: at 1 month (+/- 1 week) and 3 months (+/- 1 month)
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
Time frame: at 1 month (+/- 1 week) and 3 months (+/- 1 month)
Assessment the plasma concentration (residual concentration at equilibrium) of ITK (pazopanib and / or cabozantinib) in patients with normal renal function
Time frame: at 1 month (+/- 1 week) and 3 months (+/- 1 month)
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)
Contact information is provided by the study sponsor or research team.
Institut du Cancer de Montpellier - Val d'Aurelle
Other
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
Acronym: IREKI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07397611
Adenocarcinoma, Carcinoma
Boston, Massachusetts, United States
View Trial DetailsNCT02346435
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Baltimore, Maryland, United States
View Trial DetailsNCT07234409
Behavior, Deception
Milan, Italy
View Trial DetailsNCT06903312
Adenocarcinoma, Carcinoma
Roma, Italy
View Trial Details