Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 4:59 AM
Study NCT ID:
NCT04320693
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2021-08-19
First Post:
2020-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access for IMMU-132
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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': 'C000608132', 'term': 'sacituzumab govitecan'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'lastUpdateSubmitDate': '2021-08-12', 'studyFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2020-03-19', 'lastUpdatePostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Metastatic Triple-Negative Breast Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is an expanded access program (EAP) for eligible participants designed to provide access to IMMU-132.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04320693', 'briefTitle': 'Expanded Access for IMMU-132', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'Expanded Access for IMMU-132', 'orgStudyIdInfo': {'id': 'IMMU-132'}}, 'armsInterventionsModule': {'interventions': [{'name': 'IMMU-132', 'type': 'DRUG', 'otherNames': ['Sacituzumab Govitecan'], 'description': 'IMMU-132 will be administered as an intravenous infusion on Days 1 and 8 of 21-day treatment cycles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}