Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-01 @ 10:48 PM
Study NCT ID:
NCT00118456
Status:
COMPLETED
Last Update Posted:
2012-01-09
First Post:
2005-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Oral AEE788 in Adults With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C489254', 'term': 'AEE 788'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'lastUpdateSubmitDate': '2012-01-05', 'studyFirstSubmitDate': '2005-07-01', 'studyFirstSubmitQcDate': '2005-07-01', 'lastUpdatePostDateStruct': {'date': '2012-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum-tolerated dose and dose-limiting toxicity of AEE788', 'timeFrame': '4.5 years'}, {'measure': 'Maximum-tolerated dose, safety and tolerability of AEE788', 'timeFrame': '4.5 years'}], 'secondaryOutcomes': [{'measure': 'Single dose and repeated dose pharmacokinetic profile of AEE788', 'timeFrame': '4.5 years'}, {'measure': 'Pharmacodynamic effects', 'timeFrame': '4.5 years'}, {'measure': 'Changes in glucose metabolism/cell viability', 'timeFrame': '4.5 years'}]}, 'conditionsModule': {'keywords': ['Advanced cancers', 'EGFR', 'Her2', 'VEGFR'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic (PK)/pharmacodynamic (PD) profiles and clinical activity of AEE788 in advanced cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed solid tumor\n* Adequate hematologic, renal and hepatic function\n* Age ≥ 18 years\n* Karnofsky performance status score ≥ 70%\n* Life expectancy ≥ 12 weeks\n\nExclusion Criteria:\n\n* Active brain metastases\n* Peripheral neuropathy \\> grade 2\n* Diarrhea \\> grade 1\n* Gastrointestinal (GI) dysfunction\n* Compromised cardiac function\n* Concurrent severe and/or uncontrolled medical conditions'}, 'identificationModule': {'nctId': 'NCT00118456', 'briefTitle': 'Study of Oral AEE788 in Adults With Advanced Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase I/II, Multicenter, Randomized Dose-Escalation Study of Oral AEE788 on Intermittent Dosing Schedules in Adult Patients With Advanced Cancer (Effective Amendment 5) Previously Entitled A Phase IA, Multicenter, Dose-Escalating Study of Oral AEE788 on a Continuous Daily Dosing Schedule in Adult Patients With Advanced Cancer', 'orgStudyIdInfo': {'id': 'CAEE788A2101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Continuous daily dosing', 'interventionNames': ['Drug: AEE788']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Monday, Wednesday, Friday Dosing', 'interventionNames': ['Drug: AEE788']}], 'interventions': [{'name': 'AEE788', 'type': 'DRUG', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '89125', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Nevada Cancer Institute', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Institute of Drug Development/Cancer Therapy and Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}