Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma

Study Overview
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Brief Summary
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The investigators hypothesize everolimus toxicities are linked to pharmacokinetic variabilities of everolimus. Thus, early detection of clinical or biological risk factors will lead to personalized dosage treatment and permit a better tolerance without altering efficacy.

Official Title
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Relation Between Safety Endpoints and Everolimus Trough Blood Level in Advanced Renal Cell Carcinoma

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Other: Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged ≥ 18 year-old. Histologically documented renal cell carcinoma whatever the type. One or two prior therapy with cytokines and/or VEFG-ligand inhibitors are permitted. Patients with an indication to receive everolimus treatment Patients able and willing to give written informed consent, before the first screening procedure. Exclusion Criteria: Patients currently receiving chemotherapy or immunotherapy Prior treatment with temsirolimus Contraindication in everolimus : Hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients. Patients with severe hepatic impairment (Child-Pugh class C) Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Pregnant or breastfeeding women Patients unwilling to or unable to comply with the protocol.

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Afinitor<br>The recommended dose of Afinitor is 10 mg everolimus once daily, at fixed hour.Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs. In case of frail patients, treatment could be initiated at a lower daily-dose (5mg/d for example) and then increase if tolerance is acceptable. | Other: Blood sample<br>* Everolimus is determined in whole blood by validated high performance liquid chromatography with tandem mass spectrometry after protein precipitation<br>* Other names: Assessment will be performed at 15 days, 1, 3 months then every three months until the end of the treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Find a relationship between everolimus through blood level and treatment safety. | We hypothesize everolimus toxicities are linked to pharmacokinetic variabilities of everolimus. Thus, early detection of clinical or biological risk factors will lead to personalised dosage treatment and permit a better tolerance without altering efficacy. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, renal, Afinitor, pharmacokinetics