Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT00169533
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rollover Study Of Lapatinib In Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077341', 'term': 'Lapatinib'}], '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': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2009-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-13', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the long-term safety and tolerability of lapatinib as monotherapy or in combination regimen', 'timeFrame': 'Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.'}], 'secondaryOutcomes': [{'measure': 'Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients, Overall survival', 'timeFrame': 'Ongoing study until the new lapatinib rollover study, EGF111767, is approved at the current sites.'}]}, 'conditionsModule': {'keywords': ['safety', 'tolerating lapatinib', 'Lapatinib'], 'conditions': ['Neoplasms, Breast']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gsk-clinicalstudyregister.com/study/EGF19060?search=study&search_terms=EGF19060#rs', 'label': 'Results for study EGF19060 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'The EGF19060 study is a rollover study to evaluate the long term safety of lapatinib and to provide lapatinib to patients who had a positive response in previous lapatinib studies until lapatinib is available pending FDA approval.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently receiving clinical benefit as defined by CR, PR or SD from treatment with lapatinib through participation in a Phase I study of lapatinib either as monotherapy or as part of a combination regimen.\n* Ability to understand and provide written informed consent to participate in this trial.\n* Is male or female.\n* Female and male subjects agree to the protocol specific birth control measures\n\nExclusion Criteria:\n\n* Permanent discontinuation of lapatinib in the previous study due to intolerance or treatment failure.\n* Is a pregnant or lactating female.\n* Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations.\n* Currently receiving treatment with any medications listed on the prohibited medication list (see Section 7.2).\n* Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.\n* Has a left ventricular ejection fraction (LVEF) \\< 40% based on MUGA or ECHO.'}, 'identificationModule': {'nctId': 'NCT00169533', 'briefTitle': 'Rollover Study Of Lapatinib In Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open Label, Phase 1b Rollover Study to Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients.', 'orgStudyIdInfo': {'id': 'EGF19060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Lapatinib either 750, 1000, 1250 or 1500 mgs', 'interventionNames': ['Drug: GW572016 oral tablets']}], 'interventions': [{'name': 'GW572016 oral tablets', 'type': 'DRUG', 'description': 'Lapatinib either at 750, 1000, 1250 or 1500 mgs', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}