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

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.

Study Overview

Status

Recruiting

Conditions

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

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Marseille, France, 13005
      • Montpellier, France, 34298
      • Montpellier, France, 34295
        • Recruiting
        • CHU Montpellier - Hopital St Eloi
        • Contact:
      • Nîmes, France, 30029
        • Recruiting
        • CHU de Nîmes, Institut de Cancérologie du Gard
        • Contact:
      • Toulouse, France, 31059
        • Recruiting
        • Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fanny LEENHARDT, Dr, Institut du Cancer de Montpellier (ICM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2021

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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