Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT02904850
Status:
UNKNOWN
Last Update Posted:
2016-09-19
First Post:
2014-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Kinetic Model of Erlotinib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-13', 'studyFirstSubmitDate': '2014-04-03', 'studyFirstSubmitQcDate': '2016-09-13', 'lastUpdatePostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between plasma concentrations of erlotinib concentrations observed and predictive model', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Correlation of Blood levels outsized with severe side effects or compromising the vital prognosis (treatment response, adherence (assessed by the test Morisky Green)', 'timeFrame': '1 year', 'description': '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.\n\nEvaluation of the potential clinical benefit to provide a dosage of erlotinib'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-small cell lung cancer', 'locally advanced or metastatic', 'erlotinib monotherapy'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients treated in the care departement of the hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Age\\> 18 years\n* Subject has signed an informed consent\n* Treatment initiated for at least 7 days or dosage changed for at least 7 days\n\nExclusion Criteria:\n\n* Contraindication to the use of drug\n* Subject to exclusion period (as determined by a previous study or in progress)\n* Inability to give informed information (subject in emergency situations, difficulties in understanding the subject, ...)\n* Subject under judicial protection\n* Subject under tutorship or curatorship\n* Pregnancy (and woman of childbearing age without contraception)\n* Breastfeeding'}, 'identificationModule': {'nctId': 'NCT02904850', 'briefTitle': 'Validation of a Kinetic Model of Erlotinib', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Validation of a Kinetic Model of Erlotinib', 'orgStudyIdInfo': {'id': '5615'}, 'secondaryIdInfos': [{'id': '2013-A01122-43'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'group of patients', 'description': 'Plasma dosage of erlotinib and OSI-420', 'interventionNames': ['Biological: group of patients']}], 'interventions': [{'name': 'group of patients', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['group of patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'state': 'Alsace', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand MENNECIER', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alain DUCOLONE', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nathalie PRIM', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cesar MATAU', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ashok PUROHIT', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de Pneumologie Nouvel Hôpital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Anne Elisabeth QUOIX', 'role': 'CONTACT', 'email': 'elisabeth.quoix@chru-strasbourg.fr', 'phone': '03 69 55 03 78'}], 'overallOfficials': [{'name': 'Anne Elisabeth QUOIX', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service Pneumologie Hôpitaux Universitaires Strasbourg 67 091 STRASBOURG cedex'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}