Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT00754104
Status:
WITHDRAWN
Last Update Posted:
2011-01-19
First Post:
2008-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of ABT-869 in Combination With Tarceva in Subjects With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'C513486', 'term': 'linifanib'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}], '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'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'lastUpdateSubmitDate': '2011-01-17', 'studyFirstSubmitDate': '2008-09-15', 'studyFirstSubmitQcDate': '2008-09-15', 'lastUpdatePostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': 'Day 7, 15, 21, 35 and Day 1 of every 8 weeks'}]}, 'conditionsModule': {'conditions': ['Solid Tumors']}, 'descriptionModule': {'briefSummary': 'Study of ABT-869 in Combination with Tarceva in Subjects with Solid Tumors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must have a histologically or cytologically confirmed non-hematologic malignancy.\n* Subject must have an ECOG Score of 0-2.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Subject has received targeted VEGF/PDGF therapy (tyrosine kinase inhibitor) therapy. Prior Avastin allowed.\n* Subject has untreated brain or meningeal metastases.\n* History of greater than 10% weight loss.\n* Has clinically relevant hemoptysis.\n* Subject has proteinuria CTC grade \\> 1.\n* Must not have had radiation therapy or major surgery within 21 days of study day 1.\n* The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (DBP) \\> 100 mmHg or systolic blood pressure (SBP) \\> 150 mmHg. Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention.\n* The subject has a documented left ventricular ejection fraction (LVEF) \\< 50%.'}, 'identificationModule': {'nctId': 'NCT00754104', 'briefTitle': 'Study of ABT-869 in Combination With Tarceva in Subjects With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Phase 1, Open Label Study of ABT-869 in Combination With Tarceva in Subjects With Advanced Non-hematologic Malignancy', 'orgStudyIdInfo': {'id': 'M10-371'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: ABT-869', 'Drug: Tarceva']}], 'interventions': [{'name': 'ABT-869', 'type': 'DRUG', 'description': '0.25 mg/kg. daily.', 'armGroupLabels': ['A']}, {'name': 'Tarceva', 'type': 'DRUG', 'description': '150mg, daily.', 'armGroupLabels': ['A']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Rod Humerickhouse, Global Project Head, Oncology', 'oldOrganization': 'Abbott'}}}}