Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-01-03 @ 6:42 PM
Study NCT ID:
NCT00683306
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2018-09-13
First Post:
2008-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'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': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'statusVerifiedDate': '2018-08', 'lastUpdateSubmitDate': '2018-09-12', 'studyFirstSubmitDate': '2008-05-21', 'studyFirstSubmitQcDate': '2008-05-22', 'lastUpdatePostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-05-23', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Non Small Cell Lung Cancer (NSCLC)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide gefitinib treatment to patients who, on completion or closure of other gefitinib clinical studies, were either receiving placebo treatment, or are continuing on the same dose and regimen of gefitinib established in their preceding study, for as long as the patients continue to derive benefit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who have completed preceding gefitinib therapy from either the 1839IL/0709 (250mg dosing) study or 1839IL/0710 (250mg dosing) study and in the opinion of the investigator may benefit from further gefitinib treatment.\n* No more than 14 days lapse in gefitinib treatment between the patient completing the preceding gefitinib clinical study and beginning of this study except when agreed by the AstraZeneca physician.\n\nExclusion Criteria:\n\n* Any evidence of clinically active interstitial lung disease (patients with chronic,stable, radiographic changes who are asymptomatic need not be excluded).\n* In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).\n* Withdrawal, at any time, from the preceding gefitinib study.\n* Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort"}, 'identificationModule': {'nctId': 'NCT00683306', 'briefTitle': 'Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment', 'orgStudyIdInfo': {'id': 'D791AC00008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ZD1839 (Iressa)', 'type': 'DRUG', 'otherNames': ['Iressa'], 'description': 'Gefitinib supplied for oral use at the dose and schedule that the patient received in the previous gefitinib clinical study. In the case of placebo patients, the gefitinib dose will be as described in the protocol of their previous gefitinib clinical study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1900', 'city': 'La Plata', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': '2139', 'city': 'Concord', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -33.84722, 'lon': 151.10381}}, {'zip': 'AT-8306', 'city': 'Graz', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Research Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': ':60431-970', 'city': 'Fortaleza', 'country': 'Brazil', 'facility': 'Research Site', 'geoPoint': {'lat': -3.71722, 'lon': 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'overallOfficials': [{'name': 'Yuri Rukazenkov', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}