Validation of a Kinetic Model of Erlotinib

University Hospital, Strasbourg, France

Status

Unknown

Conditions

Lung Cancer

Treatments

Biological: group of patients

Study type

Observational

Funder types

Other

Identifiers

NCT02904850

2013-A01122-43

5615

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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