Kidney NeoplasmIREKINCT04823923
Impact of Chronic Renal Failure on Plasma Exposure of Kinase Inhibitors in Patients Treated for Metastatic Kidney Cancer
A study testing blood sampling for ITK dosage in people with Kidney Neoplasm, run by Institut du Cancer de Montpellier - Val d'Aurelle at 5 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Neoplasm
- What is being tested?
- blood sampling for ITK dosage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesFrance
- Study dates
- 6 Dec 2021to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
APHM Hôpital LA TIMONE
Marseille, 13005
Laurent DEVILLE, Dr, 04 91 38 57 08 ext. +33, jean-laurent.deville@ap-hm.fr
- Recruiting
CHU Montpellier - Hôpital St Eloi
Montpellier, 34295
Delphine TOPART, Dr, 04 67 33 01 37 ext. +33, d-topart@chu-montpellier.fr
- Recruiting
ICM Val d'Aurelle
Montpellier, 34298
Fanny LEENHARDT, Dr, 04 67 61 24 77 ext. +33, Fanny.Leenhardt@icm.unicancer.fr
- Recruiting
CHU de Nîmes, Institut de Cancérologie du Gard
Nîmes, 30029
Nadine HOUEDE, Pr, 04 66 68 33 01 ext. +33, nadine.houede@chu-nimes.fr
- Recruiting
Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
Toulouse, 31059
Loïc MOUREY, Dr, 05 31 15 51 67 ext. +33, mourey.loic@iuct-oncopole.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Neoplasm
- Being tested
- blood sampling for ITK dosage
- Keywords
- metastatic kidney cancer, pazopanib, cabozantinib, renal failure
- Medical subject headings
- Kidney Neoplasms, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampling for ITK dosageOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Patients without renal insufficiency under pazopanib | Other | Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription. Receives: Other: blood sampling for ITK dosage |
| Patients without renal insufficiency under cabozantinib | Other | Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription. Receives: Other: blood sampling for ITK dosage |
| Patients with moderate renal impairment under pazopanib | Other | Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription. Receives: Other: blood sampling for ITK dosage |
| Patients with moderate renal impairment under cabozantinib | Other | Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription. Receives: Other: blood sampling for ITK dosage |
| Patients with severe or terminal stage renal impairment under pazopanib | Other | Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription. Receives: Other: blood sampling for ITK dosage |
| Patients with severe or terminal stage renal impairment under cabozantinib | Other | Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription. Receives: Other: blood sampling for ITK dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual concentration at equilibrium of ITK in the blood
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 )
Measured: at 1 month (+/1 week)
Secondary outcomes (3)
Concentration of ITK in the blood in patients with Failure renal function
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
Measured: at 1 month (+/- 1 week) and 3 months (+/- 1 month)
Concentration of ITK in the blood in patients with normal renal function
Assessment the plasma concentration (residual concentration at equilibrium) of ITK (pazopanib and / or cabozantinib) in patients with normal renal function
Measured: at 1 month (+/- 1 week) and 3 months (+/- 1 month)
Toxicities related to the intake of ITKs
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)
Measured: at 1 month (+/- 1 week) and 3 months (+/- 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start6 Dec 2021
- Primary completionJan 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney NeoplasmStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Responsible party
- Sponsor
- Investigators
- Fanny LEENHARDT, Dr, Principal investigator, Institut du Cancer de Montpellier (ICM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823923
- Sponsor's protocol ID
- PROICM 2020-08 IRE
- Other IDs
- 2020-A01533-36
- Acronym
- IREKI
- Status last verified
- Feb 2025
- First submitted
- 22 Mar 2021
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
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.
PubMed 19733976Hendrayana 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.
PubMed 28264440Verheijen 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.
PubMed 27470967Lacy 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.
PubMed 29687244
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04823923
- Acronym / sponsor ID
- IREKI / PROICM 2020-08 IRE
- Conditions
- Kidney Neoplasm
- Keywords
- metastatic kidney cancer, pazopanib, cabozantinib, renal failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Patients without renal insufficiency under pazopanib | Other | Other: blood sampling for ITK dosagePazopanib is taken daily, for a minimum of 3 months, according to the medical prescription. |
| Patients without renal insufficiency under cabozantinib | Other | Other: blood sampling for ITK dosageCabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription. |
| Patients with moderate renal impairment under pazopanib | Other | Other: blood sampling for ITK dosagePazopanib is taken daily, for a minimum of 3 months, according to the medical prescription. |
| Patients with moderate renal impairment under cabozantinib | Other | Other: blood sampling for ITK dosageCabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription. |
| Patients with severe or terminal stage renal impairment under pazopanib | Other | Other: blood sampling for ITK dosagePazopanib is taken daily, for a minimum of 3 months, according to the medical prescription. |
| Patients with severe or terminal stage renal impairment under cabozantinib | Other | Other: blood sampling for ITK dosageCabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampling for ITK dosageBlood 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, Patients with moderate renal impairment under pazopanib, Patients with severe or terminal stage renal impairment under cabozantinib, Patients with severe or terminal stage renal impairment under pazopanib, Patients without renal insufficiency under cabozantinib, Patients without renal insufficiency under pazopanib |
Primary outcome
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 )
3 secondary outcomes
Concentration of ITK in the blood in patients with Failure renal function
Time frame: 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)
Toxicities related to the intake of ITKs
Time frame: at 1 month (+/- 1 week) and 3 months (+/- 1 month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Background: PubMed 19733976van 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.
- Background: PubMed 28264440Hendrayana 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.
- Background: PubMed 27470967Verheijen 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.
- Background: PubMed 29687244Lacy 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.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fanny LEENHARDT, Dr principal investigator
Institut du Cancer de Montpellier (ICM)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling for ITK dosage in people with Kidney Neoplasm, run by Institut du Cancer de Montpellier - Val d'Aurelle at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurore MOUSSION (04 67 61 31 02 ext. +33, DRCI-icm105@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual concentration at equilibrium of ITK in the blood (time frame: at 1 month (+/1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04823923, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.