- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04823923
Impact of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors in Patients Treated for Metastatic Kidney Cancer (IREKI)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aurore Moussion
- Phone Number: +33 04 67 61 31 02
- Email: DRCI-icm105@icm.unicancer.fr
Study Contact Backup
- Name: Emmanuelle Texier
- Phone Number: +33 04 67 61 31 02
- Email: DRCI-icm105@icm.unicancer.fr
Study Locations
-
-
-
Marseille, France, 13005
- Recruiting
- APHM Hôpital la Timone
-
Contact:
- Laurent DEVILLE, Dr
- Phone Number: +33 04 91 38 57 08
- Email: jean-laurent.deville@ap-hm.fr
-
Montpellier, France, 34298
- Recruiting
- ICM Val d'Aurelle
-
Contact:
- Fanny LEENHARDT, Dr
- Phone Number: +33 04 67 61 24 77
- Email: Fanny.Leenhardt@icm.unicancer.fr
-
Montpellier, France, 34295
- Recruiting
- CHU Montpellier - Hopital St Eloi
-
Contact:
- Delphine TOPART, Dr
- Phone Number: +33 04 67 33 01 37
- Email: d-topart@chu-montpellier.fr
-
Nîmes, France, 30029
- Recruiting
- CHU de Nîmes, Institut de Cancérologie du Gard
-
Contact:
- Nadine HOUEDE, Pr
- Phone Number: +33 04 66 68 33 01
- Email: nadine.houede@chu-nimes.fr
-
Toulouse, France, 31059
- Recruiting
- Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
-
Contact:
- Loïc MOUREY, Dr
- Phone Number: +33 05 31 15 51 67
- Email: mourey.loic@iuct-oncopole.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient followed for metastatic clear cell renal cell carcinoma.
- Age ≥18 years old.
- Performance Status (PS) according to Eastern Cooperative Oncology Group (ECOG) = 0, 1 or 2
- Patient treated with a VEGF-R inhibitor: pazopanib or cabozantinib for metastatic kidney cancer.
- 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.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Patient having given informed, written and express consent.
- Affiliation to the French Social Security System.
Exclusion Criteria:
- Indication other than clear cell renal cell carcinoma for these same ITKs
- Pregnant or breast-feeding subjects
- Patient whose regular follow-up is impossible for psychological, family, social or geographic reasons,
- Patient under guardianship, curatorship or safeguard of justice
- Participation in another clinical study with a research product during the last 30 days before inclusion.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patients without renal insufficiency under pazopanib
Pazopanib 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)
|
Other: Patients without renal insufficiency under cabozantinib
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)
|
Other: Patients with moderate renal impairment under pazopanib
Pazopanib 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)
|
Other: Patients with moderate renal impairment under cabozantinib
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)
|
Other: 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 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)
|
Other: 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 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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Residual concentration at equilibrium of ITK in the blood
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 )
|
at 1 month (+/1 week)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of ITK in the blood in patients with Failure renal function
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
|
at 1 month (+/- 1 week) and 3 months (+/- 1 month)
|
Concentration of ITK in the blood in patients with normal renal function
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
|
at 1 month (+/- 1 week) and 3 months (+/- 1 month)
|
Toxicities related to the intake of ITKs
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)
|
at 1 month (+/- 1 week) and 3 months (+/- 1 month)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Fanny LEENHARDT, Dr, Institut du Cancer de Montpellier (ICM)
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Disease Attributes
- Renal Insufficiency, Chronic
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Kidney Failure, Chronic
- Renal Insufficiency
Other Study ID Numbers
- PROICM 2020-08 IRE
- 2020-A01533-36 (Other Identifier: ID RCB number of competent autority in France)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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