Validation of a Kinetic Model of Erlotinib

Study Overview
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Brief Summary
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Several arguments are in favor of a therapeutic monitoring for the erlotinib, therefore, a pharmacokinetic (PK) has been prepared using data from the literature. This model must be validated at concentrations achieved in practice. This is a preliminary study before the implementation of a randomized trial confirming the therapeutic monitoring of erlotinib through this model.

Official Title
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Validation of a Kinetic Model of Erlotinib

Conditions
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Lung Cancer

Intervention / Treatment
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* Biological: group of patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients receiving treatment with erlotinib monotherapy for locally advanced or metastatic NSCLC either first line in patients with an activating mutation of the receptor EGF-R or patients with stable disease after 4 cycles of standard first-line chemotherapy with platinum or after failure of at least one prior chemotherapy regimen Age> 18 years Subject has signed an informed consent Treatment initiated for at least 7 days or dosage changed for at least 7 days Exclusion Criteria: Contraindication to the use of drug Subject to exclusion period (as determined by a previous study or in progress) Inability to give informed information (subject in emergency situations, difficulties in understanding the subject, ...) Subject under judicial protection Subject under tutorship or curatorship Pregnancy (and woman of childbearing age without contraception) Breastfeeding

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group of patients<br>Plasma dosage of erlotinib and OSI-420 | Biological: group of patients<br>* Plasma dosage of erlotinib and OSI-420 is made from the blood usually taken Further information are collected in the medical record of the patient during the CT scan reassessment after collection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between plasma concentrations of erlotinib concentrations observed and predictive model |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Blood levels outsized with severe side effects or compromising the vital prognosis (treatment response, adherence (assessed by the test Morisky Green) | Evaluation of interest to assay the active metabolite OSI-420 Observation between incidence of clinical problems (ineffectiveness, toxicity, adherence) and blood concentrations of erlotinib outsized. Evaluation of the potential clinical benefit to provide a dosage of erlotinib | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small cell lung cancer, locally advanced or metastatic, erlotinib monotherapy