Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-04-04 @ 4:34 PM
Study NCT ID:
NCT00502060
Status:
COMPLETED
Last Update Posted:
2009-05-14
First Post:
2007-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of AZD2171 co-Administered With Fixed Multiple Oral Doses of ZD1839 in Patients With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C500926', 'term': 'cediranib'}, {'id': 'D000077156', 'term': 'Gefitinib'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-13', 'studyFirstSubmitDate': '2007-07-13', 'studyFirstSubmitQcDate': '2007-07-13', 'lastUpdatePostDateStruct': {'date': '2009-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'primary objective is to determine the safety and tolerability of multiple oral doses fo AZD2171 when co-administered with fixed daily oral doses of ZD1839'}], 'secondaryOutcomes': [{'measure': 'to explore the PK of AZD2171 when given alone for 7 days and in combination with ZD1839 for 14 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Phase I', 'AZD2171', 'ZD1839', 'solid tumor'], 'conditions': ['Advanced Tumor']}, 'descriptionModule': {'briefSummary': 'Phase I AZD2171 in combination with ZD1839 study recruiting patients with advanced cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* tumor progressed on standard therapy or ineligible for standard therapy\n* life expectancy of 12 weeks or more\n* WHO performance status 0-2\n\nExclusion Criteria:\n\n* History of active interstitial lung disease'}, 'identificationModule': {'nctId': 'NCT00502060', 'briefTitle': 'Phase I Study of AZD2171 co-Administered With Fixed Multiple Oral Doses of ZD1839 in Patients With Advanced Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I Open-Label Study to Assess the Safety, Tolerability and PK of Ascending Multiple Oral Doses of AZD2171 When co-Administered With Fixed Multiple Oral Doses of ZD1839 (250mg or 500mg Once Daily) in Patients With Advanced Cancer', 'orgStudyIdInfo': {'id': 'D8480C00004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AZD2171', 'type': 'DRUG'}, {'name': 'ZD1839', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Nick Botwood, BSc, MBBS, MRCP, MFPM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'G Giaccone, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vrije Universiteit Medical Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}