Validation of a Kinetic Model of Erlotinib

NCT02904850 | Unknown

• 2 other identifiers: 56152013-A01122-43
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

Non-small cell lung cancer; locally advanced or metastatic; erlotinib monotherapy

Outcome Measures

Primary Outcomes (1)

• Difference between plasma concentrations of erlotinib concentrations observed and predictive model

  1 year

Secondary Outcomes (1)

• Correlation of Blood levels outsized with severe side effects or compromising the vital prognosis (treatment response, adherence (assessed by the test Morisky Green)

  1 year

Study Arms (1)

group of patients

Plasma dosage of erlotinib and OSI-420

Biological: group of patients

Interventions

group of patients BIOLOGICAL

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.

group of patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients treated in the care departement of the hospital

You may qualify if:

• 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

You may not qualify if:

• Contraindication to the use of drug
• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Pneumologie Nouvel Hôpital Civil

Strasbourg, Alsace, 67091, France

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Elisabeth QUOIX

  Service Pneumologie Hôpitaux Universitaires Strasbourg 67 091 STRASBOURG cedex

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Elisabeth QUOIX

CONTACT

03 69 55 03 78; elisabeth.quoix@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: September 19, 2016
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 19, 2016

Record last verified: 2016-09

Locations

FR (1)