Ignite Creation Date:
2025-12-17 @ 2:47 PM
Ignite Modification Date:
2025-12-23 @ 4:55 PM
Study NCT ID:
NCT01770795
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2013-01-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'lastUpdateSubmitDate': '2013-01-16', 'studyFirstSubmitDate': '2013-01-16', 'studyFirstSubmitQcDate': '2013-01-16', 'lastUpdatePostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': 'one year'}, {'measure': 'overall survival', 'timeFrame': 'one year'}, {'measure': 'toxicities', 'timeFrame': 'one year'}]}, 'conditionsModule': {'keywords': ['non-small cell lung cancer', 'gemcitabine', 'genexol-PM', 'paclitaxel'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety Genexol-PM(CrEL-free polymeric micelle formulated paclitaxel)and gemcitabine in untreated metastatic NSCLC patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 18\n* histologically or cytologically confirmted non-small cell lung cancer\n* stage IIIb with pleural effusion or stage IV\n* ECOG PS 0-2\n* at least one measurable lesion\n* expected life span more than 3 months\n* normal bone marrow, liver, renal function\n* no prior chemotherapy or radiotherapy except for whole brain radiotherapy for symptomatic brain metastases\n* more than 6 months from the last adjuvant chemotherapy\n\nExclusion Criteria:\n\n* active infection\n* severe comorbitidies\n* pregnant or lactating women\n* other invasive malignancies\n* poorly controlled symptomatic brain metastases'}, 'identificationModule': {'nctId': 'NCT01770795', 'briefTitle': 'A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'A Phase II Trial of Genexol-PM and Gemcitabine in Patients With Advanced Non-small-cell Lung Cancer', 'orgStudyIdInfo': {'id': '2011-GIRBA-2351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Genexol-PM/Gemcitabine', 'interventionNames': ['Drug: Genexol-PM/Gemcitabine']}], 'interventions': [{'name': 'Genexol-PM/Gemcitabine', 'type': 'DRUG', 'armGroupLabels': ['Genexol-PM/Gemcitabine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eun Kyung Cho', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}