Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-28 @ 12:26 AM
Study NCT ID:
NCT00655161
Status:
COMPLETED
Last Update Posted:
2014-01-29
First Post:
2008-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Phase 2 Trial of the Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant S. Cerevisiae Expressing Mutant Ras Protein, as Consolidation Therapy Following Curative Treatment for Stage I-III Non-Small Cell Lung Cancer (NSCLC) With Tumor Sequence Confirmation of K-ras Mutation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-07-16', 'releaseDate': '2014-06-17'}], 'estimatedResultsFirstSubmitDate': '2014-06-17'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-28', 'studyFirstSubmitDate': '2008-04-02', 'studyFirstSubmitQcDate': '2008-04-08', 'lastUpdatePostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immune response to GI-4000', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NSCLC', 'Cancer Immunotherapy'], 'conditions': ['NSCLC']}, 'descriptionModule': {'briefSummary': 'This is a consolidation therapy trial evaluating GI-4000 in subjects with NSCLC treated with curative intent who are disease free at their first post-treatment restaging assessment.', 'detailedDescription': 'NSCLC is the deadliest form of human cancer, killing approximately 150,000 people a year in the United States. The best treatment for NSCLC is surgical resection. For patients with inoperable or unresectable NSCLC chemotherapy and radiation is used as first line therapy. This is a consolidation therapy trial evaluating GI-4000 in subjects with NSCLC treated with curative intent who are disease free at their first post-treatment restaging assessment. These subjects must also have a ras mutation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically proven stage I-III NSCLC\n* Confirmed product related ras mutation\n* ECOG performance status of less than or equal to 2\n* greater than or equal to 18 years of age\n\nExclusion Criteria:\n\n* History of a previous cancer\n* History of splenectomy\n* History of Crohns disease or ulcerative colitis\n* History of major organ transplantation\n* Concurrent or chronic steroid therapy\n* History of allergy to yeast\n* Presence of an unstable or poorly controlled medical condition\n* Pregnant or nursing mothers\n* Positive skin test to yeast'}, 'identificationModule': {'nctId': 'NCT00655161', 'briefTitle': 'A Pilot Phase 2 Trial of the Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant S. Cerevisiae Expressing Mutant Ras Protein, as Consolidation Therapy Following Curative Treatment for Stage I-III Non-Small Cell Lung Cancer (NSCLC) With Tumor Sequence Confirmation of K-ras Mutation', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlobeImmune'}, 'officialTitle': 'A Pilot Phase 2 Trial of the Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant Saccharomyces Cerevisiae Expressing Mutant Ras Protein, as Consolidation Therapy Following Curative Treatment for Stage I-III Non-Small Cell Lung Cancer (NSCLC) With Tumor Sequence Confirmation of K-ras Mutation', 'orgStudyIdInfo': {'id': 'GI-4000-03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'GI-4000', 'type': 'BIOLOGICAL', 'description': 'subcutaneous injection, 40YU weekly for 3 weeks followed by monthly for 6 months them quarterly until recurrence'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jamie Chaft, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlobeImmune', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-06-17', 'type': 'RELEASE'}, {'date': '2014-07-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'GlobeImmune'}}}}