Validation of a Kinetic Model of Erlotinib

Lung Cancer Clinical Trial

Official title:

Validation of a Kinetic Model of Erlotinib

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02904850
• Other study ID #: 5615
• Secondary ID: 2013-A01122-43
• Status: Recruiting
• Phase: N/A
• First received: April 3, 2014
• Last updated: September 13, 2016
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: University Hospital, Strasbourg, France
• Contact: Anne Elisabeth QUOIX
• Phone: 03 69 55 03 78
• Email: elisabeth.quoix[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Ministère de l'Enseignement supérieur et de la Recherche
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Biological:
• group of patients
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.

Locations

Country	Name	City	State
France	Service de Pneumologie Nouvel Hôpital Civil	Strasbourg	Alsace

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between plasma concentrations of erlotinib concentrations observed and predictive model		1 year	No
Secondary	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	No