Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-31 @ 9:28 AM
Study NCT ID:
NCT01049061
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2010-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MORAb-003 in Patients With Solid Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527484', 'term': 'farletuzumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-08', 'studyFirstSubmitDate': '2010-01-13', 'studyFirstSubmitQcDate': '2010-01-13', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate dose-limiting toxicity and estimate maximum tolerated dose.', 'timeFrame': '7 weeks'}]}, 'conditionsModule': {'keywords': ['Cancer', 'FRα'], 'conditions': ['Neoplasms', 'Solid Tumor']}, 'referencesModule': {'references': [{'pmid': '25380636', 'type': 'DERIVED', 'citation': 'Sasaki Y, Miwa K, Yamashita K, Sunakawa Y, Shimada K, Ishida H, Hasegawa K, Fujiwara K, Kodaira M, Fujiwara Y, Namiki M, Matsuda M, Takeuchi Y, Katsumata N. A phase I study of farletuzumab, a humanized anti-folate receptor alpha monoclonal antibody, in patients with solid tumors. Invest New Drugs. 2015 Apr;33(2):332-40. doi: 10.1007/s10637-014-0180-8. Epub 2014 Nov 9.'}]}, 'descriptionModule': {'briefSummary': 'MORAb-003 is intravenously administered to Japanese patients with folate receptor-alpha expressing solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria;\n\n1. Japanese male and female aged \\>or=20 to \\<80 years at obtaining informed consent\n2. Patient with histologically or cytologically diagnosed solid tumor\n3. Patient who is FRα-positive confirmed by immunohistochemistry (IHC) (except for ovarian cancer that FRα-positive is frequently reported)\n4. Patients with a folate-receptor alpha expressing solid tumor who are not responsive or resistant to standard therapy and have no other appropriate treatment\n5. Performance Status (PS) is 0 to 1 by Eastern Cooperative Oncology Group（ECOG）criteria\n\nExclusion criteria\n\n1. Brain metastasis presenting clinical symptoms or requiring medical treatment\n2. Serious and systemic infection requiring medical treatment\n3. History of hypersensitivity to protein formulations including monoclonal antibody\n4. With other active malignancy (except for carcinoma in situ)\n5. With a large volume of pleural effusion or ascites requiring drainage'}, 'identificationModule': {'nctId': 'NCT01049061', 'briefTitle': 'A Study of MORAb-003 in Patients With Solid Tumor', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Phase 1 Study of MORAb-003 in Patients With Solid Tumor', 'orgStudyIdInfo': {'id': 'MORAB-003-J081-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MORAb-003', 'interventionNames': ['Drug: MORAb-003']}], 'interventions': [{'name': 'MORAb-003', 'type': 'DRUG', 'description': 'MORAb-003 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose', 'armGroupLabels': ['MORAb-003']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hidaka-shi', 'state': 'Saitama', 'country': 'Japan'}, {'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Chifumi Kitamura', 'role': 'STUDY_DIRECTOR', 'affiliation': 'JAC PCU Eisai Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}