Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-28 @ 12:14 PM
Study NCT ID:
NCT00251550
Status:
COMPLETED
Last Update Posted:
2007-11-06
First Post:
2005-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-05', 'studyFirstSubmitDate': '2005-11-08', 'studyFirstSubmitQcDate': '2005-11-08', 'lastUpdatePostDateStruct': {'date': '2007-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the recommended dose of LY231514 and cisplatin combination therapy, Response Rate'}], 'secondaryOutcomes': [{'measure': 'Duration of response'}, {'measure': 'Progression free survival'}, {'measure': 'Median survival time'}, {'measure': '1 year survival rate'}, {'measure': 'Pulmonary function'}, {'measure': 'QOL'}, {'measure': 'Safety'}, {'measure': 'Plasma concentration'}]}, 'conditionsModule': {'conditions': ['Malignant Pleural Mesotherioma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'To investigate efficacy and safety of pemetrexed combined with cisplatin for chemo-naive patients with Malignant Pleural Mesothelioma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inapplicable for radical operation\n* Not received prior systemic chemotherapy\n* Performance status: 0-1\n\nExclusion Criteria:\n\n* Having a history of sensitivity to platinum agent, folic acid or vitamin B12'}, 'identificationModule': {'nctId': 'NCT00251550', 'briefTitle': 'Study of Pemetrexed Plus Cisplatin in Patients With Malignant Pleural Mesothelioma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Phase I/II Study of LY231514 Plus Cisplatin in Patients With Malignant Pleural Mesothelioma', 'orgStudyIdInfo': {'id': '5249'}, 'secondaryIdInfos': [{'id': 'H3E-JE-ME01'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Pemetrexed', 'type': 'DRUG'}, {'name': 'Cisplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Ehime', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician'}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician'}, {'city': 'Okayama', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time(UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}}}}