Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT03058406
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2017-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C490954', 'term': 'eribulin'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-03', 'studyFirstSubmitDate': '2017-02-16', 'studyFirstSubmitQcDate': '2017-02-16', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Events (AEs) and Adverse Drug Reactions (ADRs)', 'timeFrame': 'up to 2 years'}], 'secondaryOutcomes': [{'measure': 'Survival Rate at Year 2', 'timeFrame': 'up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcoma, Soft Tissue', 'Halaven Injection', 'E7389'], 'conditions': ['Sarcoma, Soft Tissue']}, 'referencesModule': {'references': [{'pmid': '35546669', 'type': 'DERIVED', 'citation': 'Kawai A, Narahara H, Takahashi S, Nakamura T, Kobayashi H, Megumi Y, Matsuoka T, Kobayashi E. Safety and effectiveness of eribulin in Japanese patients with soft tissue sarcoma including rare subtypes: a post-marketing observational study. BMC Cancer. 2022 May 11;22(1):528. doi: 10.1186/s12885-022-09527-y.'}, {'pmid': '31365116', 'type': 'DERIVED', 'citation': 'Kobayashi E, Naito Y, Asano N, Maejima A, Endo M, Takahashi S, Megumi Y, Kawai A. Interim results of a real-world observational study of eribulin in soft tissue sarcoma including rare subtypes. Jpn J Clin Oncol. 2019 Oct 1;49(10):938-946. doi: 10.1093/jjco/hyz096.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand safety and efficacy in participants with soft tissue sarcomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with soft tissue sarcoma who will receive eribulin mesylate per the approved indication in routine clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Participants with soft tissue sarcoma who will receive eribulin mesylate per the approved indication in routine clinical practice\n\nExclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT03058406', 'acronym': 'HAL03T', 'briefTitle': 'A Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'Special Use Investigation of HALAVEN (HAL03T) - Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas', 'orgStudyIdInfo': {'id': 'E7389-M081-503'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Eribulin mesylate', 'interventionNames': ['Drug: Eribulin mesylate']}], 'interventions': [{'name': 'Eribulin mesylate', 'type': 'DRUG', 'otherNames': ['Halaven Injection', 'E7389'], 'description': 'Participants will receive 1.4 milligrams per square meter (mg/m2) administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle and beyond.', 'armGroupLabels': ['Eribulin mesylate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}