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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01533-36 | Other Identifier | ID RCB number of competent autority in France |
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| Name | Class |
|---|---|
| Ligue contre le cancer, France | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients without renal insufficiency under pazopanib | Other | Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription. |
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| Patients without renal insufficiency under cabozantinib | Other | Cabozantinib is taken daily, for a minimum of 3 months, according to the medical prescription. |
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| Patients with moderate renal impairment under pazopanib | Other | Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription. |
|
| Patients with moderate renal impairment under cabozantinib | Other | Cabozantinib 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 | Pazopanib is taken daily, for a minimum of 3 months, according to the medical prescription. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sampling for ITK dosage | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 ) | at 1 month (+/1 week) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 1 month (+/- 1 week) and 3 months (+/- 1 month) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aurore MOUSSION | Contact | 04 67 61 31 02 | +33 | DRCI-icm105@icm.unicancer.fr |
| Emmanuelle TEXIER | Contact | 04 67 61 31 02 | +33 | DRCI-icm105@icm.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Fanny LEENHARDT, Dr | Institut du Cancer de Montpellier (ICM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHM Hôpital LA TIMONE | Recruiting | Marseille | 13005 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19733976 | Background | 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. | |
| 28264440 | Background | 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. |
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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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| 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. |
|
| 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 |
| 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) | at 1 month (+/- 1 week) and 3 months (+/- 1 month) |
| CHU Montpellier - Hôpital St Eloi | Recruiting | Montpellier | 34295 | France |
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| ICM Val d'Aurelle | Recruiting | Montpellier | 34298 | France |
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| CHU de Nîmes, Institut de Cancérologie du Gard | Recruiting | Nîmes | 30029 | France |
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| Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole | Recruiting | Toulouse | 31059 | France |
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| 27470967 | Background | 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. |
| 29687244 | Background | 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. |
| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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