Informations générales (source: ClinicalTrials.gov)
Validation of a Kinetic Model of Erlotinib
Observational
University Hospital, Strasbourg, France (Voir sur ClinicalTrials)
juin 2014
décembre 2016
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Service de Pneumologie Nouvel Hôpital Civil - 67091 - Strasbourg - Alsace - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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