Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-27 @ 7:51 AM
Study NCT ID:
NCT00890903
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
2009-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Interventional Study With Vinorelbine ORAL in Advanced Non-Small Cell Lung Carcinoma(NSCLC) and Metastatic Breast Cancer (MBC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-28', 'studyFirstSubmitDate': '2009-04-29', 'studyFirstSubmitQcDate': '2009-04-29', 'lastUpdatePostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free-survival', 'timeFrame': '1 year after LPI'}], 'secondaryOutcomes': [{'measure': 'Time to progression', 'timeFrame': '1 year after LPI'}, {'measure': 'Adverse reactions', 'timeFrame': '1 year after LPI'}, {'measure': 'Concomitant antiemetic therapy', 'timeFrame': '1 year after LPI'}, {'measure': 'Patient compliance', 'timeFrame': '1 year after LPI'}, {'measure': "Recording of combinations of applied capsules (requested by a patients' questionnaire)", 'timeFrame': '1 year after LPI'}, {'measure': "General condition of patients (requested by a patients' questionnaire)", 'timeFrame': '1 year after LPI'}, {'measure': 'Therapy performance in the daily routine', 'timeFrame': '1 year after LPI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NSCLC', 'non small cell lung carcinoma', 'metastatic breast cancer', 'MBC', 'advanced breast cancer', 'Navelbine', 'Navelbine-ORAL', 'Vinorelbine', 'Vinorelbine-ORAL', 'daily routine', 'concomitant antiemetic therapy', 'patient compliance', 'germany', 'non-interventional study', 'oral anti cancer therapy', 'quality of life'], 'conditions': ['Non Small Cell Lung Carcinoma', 'Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this non-interventional study is to collect data on efficacy and toxicity of the use of Navelbine ORAL in daily routine in Germany (especially after availability of an 80mg capsule). The study focusses on concomitant antiemetic therapy and patient compliance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced non-small cell lung cancer (NSCLC) or metastatic, Antracycline-resistant breast cancer, treated with Navelbine capsules', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years old\n* Male and female patients\n* Advanced NSCLC (Stage III or IV) or Antracycline-resistant MBC\n* Therapy with Navelbine capsules in any palliative treatment line\n* Signed patient informed consent\n\nExclusion Criteria:\n\n* Pregnancy and nursing\n* All other exclusion criteria listed in SPC (summary of product characteristics)\n* lack of signed Patient informed consent'}, 'identificationModule': {'nctId': 'NCT00890903', 'briefTitle': 'Non-Interventional Study With Vinorelbine ORAL in Advanced Non-Small Cell Lung Carcinoma(NSCLC) and Metastatic Breast Cancer (MBC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Pharma GmbH'}, 'officialTitle': 'Usage of Vinorelbin ORAL (Navelbine® ORAL) in the Treatment of Advanced Non-small Cell Lung Cancer(NSCLC)and Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'IOM-155'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NSCLC', 'description': 'Patients with advanced non-small cell lung cancer'}, {'label': 'MBC', 'description': 'Female patients with metastatic, Anthracycline-resistent breast cancer'}]}, 'contactsLocationsModule': {'locations': [{'zip': '79111', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Pierre Fabre Pharma GmbH', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Fabre Pharma GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'iOMEDICO AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}