Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2026-02-25 @ 4:05 AM
Study NCT ID:
NCT02090127
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2015-07-29
First Post:
2014-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C583360', 'term': 'ficlatuzumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2015-07', 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2014-03-14', 'studyFirstSubmitQcDate': '2014-03-14', 'lastUpdatePostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Mullerian Mixed Tumor of Ovary']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://clinicaltrials.gov/show/NCT00725634', 'label': 'Continued Access of Ficlatuzumab to P05538 Patient'}]}, 'descriptionModule': {'briefSummary': 'Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient', 'detailedDescription': 'This treatment protocol will serve as a mechanism to continue to provide ficlatuzumab to patient 0001-000412, who was previously enrolled under protocol P05538 and whom the investigator believes is deriving clinical benefit from ficlatuzumab treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Per original P05538 protocol\n\nExclusion Criteria:\n\n* Per original P05538 protocol'}, 'identificationModule': {'nctId': 'NCT02090127', 'briefTitle': 'Protocol to Allow Continued Access of Ficlatuzumab to P05538 Patient', 'organization': {'class': 'INDUSTRY', 'fullName': 'AVEO Pharmaceuticals, Inc.'}, 'officialTitle': 'Expanded Access Protocol to Provide Ficlatuzumab to P05538 Patient 0001-000412', 'orgStudyIdInfo': {'id': 'AV-299-13-103S'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ficlatuzumab', 'type': 'DRUG', 'otherNames': ['AV-299', 'SCH 900105'], 'description': 'humanized anti-hepatocyte growth factor (HGF) monoclonal antibody IV administration at 16.5mg/kg every 2 weeks with a ±2 day window around dosing dates, as long as subject is deriving clinical benefit as determined by the Investigator'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'START', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AVEO Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}