Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-28 @ 10:50 AM
Study NCT ID:
NCT00499850
Status:
COMPLETED
Last Update Posted:
2016-08-25
First Post:
2007-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I FOLFOX Combination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000230', 'term': 'Adenocarcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C452423', 'term': 'vandetanib'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-24', 'studyFirstSubmitDate': '2007-07-10', 'studyFirstSubmitQcDate': '2007-07-11', 'lastUpdatePostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin', 'timeFrame': 'Assessed at each visit'}]}, 'conditionsModule': {'keywords': ['ZD6474', 'FOLFOX', 'colorectal', 'adenocarcinoma'], 'conditions': ['Advanced Colorectal Carcinoma']}, 'descriptionModule': {'briefSummary': 'A Phase I,open label study to assess the safety and tolerability of ZD6474 in combination with 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as first and second line therapy in patients with advanced colorectal adenocarcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed locally advanced, recurrent or metastatic colorectal adenocarcinoma (Stage IV)\n2. WHO performance status 0-1\n3. one or more measurable lesions min 10mm by spiral CT or min 20mm by conventional techniques\n\nExclusion Criteria:\n\n1. Brain metastasis or spinal cord compression unless irradiated at least 4 weeks before entry and stable\n2. last dose of prior chemotherapy discontinued at least 4 weeks before start study treatment\n3. prior unanticipated severe reaction to oxaliplatin'}, 'identificationModule': {'nctId': 'NCT00499850', 'briefTitle': 'Phase I FOLFOX Combination', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Phase I,Open Label Study to Assess the Safety and Tolerability of ZD6474 in Combination With 5-Fluorouracil, Leucovorin and Oxaliplatin (mFOLFOX6) as First and Second Line Therapy in Patients With Advanced Colorectal Adenocarcinoma.', 'orgStudyIdInfo': {'id': 'D4200C00037'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ZD6474 (vandetanib)', 'type': 'DRUG', 'otherNames': ['ZACTIMA™'], 'description': 'once daily oral dose'}, {'name': '5-Fluorouracil', 'type': 'DRUG', 'otherNames': ['5-FU'], 'description': 'intravenous infusion'}, {'name': 'Leucovorin', 'type': 'DRUG', 'description': 'intravenous infusion'}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'intravenous infusion'}]}, 'contactsLocationsModule': {'locations': [{'city': 'East Melbourne', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'city': 'Footscray', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -37.8, 'lon': 144.9}}, {'city': 'Heidelberg', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'city': 'Parkville', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genzyme, a Sanofi Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}