Impact of Sunitinib Bioavailability on Toxicity and Treatment Efficacy in Patients Treated for Metastatic Renal Cancer

Study Overview
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Brief Summary
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Patients treated on the first line of Sunitinib-targeted therapy for metastatic kidney cancer. Collection of additional blood tubes during routine blood tests for patient follow-up, to evaluate the plasma concentration of Sunitinib and its active metabolite desethyl-Sunitinib (DES)

Official Title
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Impact of Sunitinib Bioavailability on Toxicity and Treatment Efficacy in Patients Treated for Metastatic Renal Cancer

Conditions
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Metastatic Kidney Cancer

Intervention / Treatment
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* Biological: blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient at least 18 years old Patient who read and understood the newsletter and signed the consent form Renal cell carcinoma histologically proven stage IV Metastatic stage proven on CT, synchronous or metachronous examination Patient operated on or not from the primary tumor Eligible for first-line systemic therapy with Sunitinib-targeted therapy for oncology urology Affiliation to a social security scheme Effective contraception (as defined by the WHO) for at least 3 months at the inclusion visit, during treatment and for 1 month after the end of the research (negative pregnancy test) Postmenopausal woman: confirmatory diagnosis (amenorrhea not clinically induced for more than 12 months at inclusion visit) General condition WHO 0 to 2 Life expectancy estimated at more than 6 months at baseline Exclusion Criteria: Non-metastatic disease Other cancer proven histologically, or in complete remission for less than 2 years Contraindication to SUTENT 50 mg hard capsules: Hypersensitivity to the active substance or to any of the excipients History of immunotherapy treatment for kidney cancer, previous treatment with targeted therapies for the same or previous cancer Pregnant or lactating woman or wishing to breastfeed within 6 months after the last treatment or no known contraception, Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-guardianship or curatorship Patient currently involved in an interventional trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: blood sample|blood sample performed on C1D1, C1D14, C2D1, C3D1 and C6D1|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | At the end of Cycle 1 (each cycle is 28 days) | 
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | At the end of Cycle 2 (each cycle is 28 days) | 
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | At the end of Cycle 3 (each cycle is 28 days) | 
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | At the end of Cycle 4 (each cycle is 28 days) | 
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | At the end of Cycle 5 (each cycle is 28 days) | 
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biologicalas according to the plasma concentration of Sunitinib | At the end of Cycle 6 (each cycle is 28 days) | 
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | At the end of Cycle 1 (each cycle is 28 days) | 
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | At the end of Cycle 2 (each cycle is 28 days) | 
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | At the end of Cycle 3 (each cycle is 28 days) | 
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | At the end of Cycle 4 (each cycle is 28 days) | 
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | At the end of Cycle 5 (each cycle is 28 days) | 
| hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | hazard ratio of a severe toxicity, grade 3-4 clinical and / or biological according to the plasma concentration of desethyl-Sunitinib | At the end of Cycle 6 (each cycle is 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma desethyl-Sunitinib (DES) concentration | influence of plasma DES concentration on patients survival | Cycle1 Day14 (each cycle is 28 days) | 
| plasma Sunitinib concentration | influence of plasma Sunitinib concentration on patients survival | Cycle1 Day14 (each cycle is 28 days) | 
| plasma Sunitinib concentration | influence of plasma Sunitinib concentration on patients survivall | Cycle1 Day28 (each cycle is 28 days) | 
| plasma DES concentration | influence of plasma Sunitinib concentration on patients survival | Cycle1 Day28 (each cycle is 28 days) | 
| plasma Sunitinib concentration | influence of plasma Sunitinib concentration on patients survival | Cycle2 Day28(each cycle is 28 days) | 
| plasma DES concentration | influence of plasma DES concentration on patients survival | Cycle2 Day28 (each cycle is 28 days) | 
| plasma Sunitinib concentration | influence of plasma Sunitinib concentration on patients survival | Cycle3 Day28 (each cycle is 28 days) | 
| plasma DES concentration | Evaluate the influence of plasma DES concentration on patients survival | Cycle3 Day28 (each cycle is 28 days) | 
| plasma Sunitinib concentration | influence of plasma Sunitinib concentration on patients survival | Cycle6 Day28 (each cycle is 28 days) | 
| plasma DES concentration | influence of plasma DES concentration on patients survival | Cycle6 Day28 (each cycle is 28 days) |