Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT00775502
Status:
TERMINATED
Last Update Posted:
2024-04-25
First Post:
2008-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1/2 Study of Anti GM-2 Monoclonal Antibody To Treat Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000596341', 'term': 'BIW-8962'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'lack of efficacy in Multiple myeloma', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2008-10-17', 'studyFirstSubmitQcDate': '2008-10-17', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum M protein levels', 'timeFrame': 'one month'}], 'secondaryOutcomes': [{'measure': 'Time to progression or death', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple myeloma', 'GM-2 ganglioside', 'monoclonal antibody', 'Potelligent design', 'Treatment of subjects who have failed previous treatment'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '28261656', 'type': 'DERIVED', 'citation': 'Baz RC, Zonder JA, Gasparetto C, Reu FJ, Strout V. Phase I Study of Anti-GM2 Ganglioside Monoclonal Antibody BIW-8962 as Monotherapy in Patients with Previously Treated Multiple Myeloma. Oncol Ther. 2016;4(2):287-301. doi: 10.1007/s40487-016-0034-y. Epub 2016 Nov 2.'}]}, 'descriptionModule': {'briefSummary': 'This study will test the ability of a specially designed monoclonal antibody to destroy multiple myeloma cells. This antibody is unique in its ability to promote the death of multiple myeloma cells by processes known as antibody dependent cellular cytotoxicity (ADCC)and complement dependent cytotoxicity (CDC). The study is designed to determine both the optimal dose of the antibody to destroy multiple myeloma cells and frequency of dosing.', 'detailedDescription': 'BIW-8962 is a monoclonal antibody which targets the GM-2 ganglioside which is expressed at high levels on the surface of multiple myeloma cells. This is a Phase 1/2 study design. The Phase 1 component will establish the active biologic dose (ABD) or the maximum tolerated dose (MTD) as well as the appropriate dosing frequency based on the pharmacokinetics of the antibody and approximately 45 subjects will be enrolled in this part of the study. The initial dosing frequency will be every two weeks and the doses to be tested will range from 0.03 mg/kg to 10 mg/kg. Once the recommended Phase 2 dose and frequency have been established in Phase 1, the efficacy of the drug will be investigated in approximately 35 subjects in Phase 2.\n\nThe study did not proceed beyond the Phase 1a portion.\n\nOn 30 Nov 2010, Kyowa Hakko Kirin Pharma, Inc. (KKP) notified Investigators of the decision to terminate BIW-8962-001 due to a lack of efficacy in Multiple Myeloma.\n\nThe Phase 1 Part B and the Phase 2 components of the study were not conducted. The study was terminated and summarized in an abbreviated clinical study report (submitted 26 June 2012; SN045). Kyowa Kirin Pharma has no current plans to pursue the use of BIW8962 in multiple myeloma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Relapsed or refractory myeloma\n* M-protein in serum and/or urine by IMWG criteria.\n* Bone marrow plasma cells or plasmacytoma\n* Related organ or tissue impairment (CRAB)\n* Subjects without detectable M protein are eligible if they have an abnormal serum free light chain ratio (FLC) or if they have at least 10% plasma cells in the bone marrow\n\nExclusion Criteria:\n\n* Ongoing infection\n* Cardiac disease\n* Uncontrolled hypertension\n* Active liver disease'}, 'identificationModule': {'nctId': 'NCT00775502', 'briefTitle': 'Phase 1/2 Study of Anti GM-2 Monoclonal Antibody To Treat Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'Open-Label, Multi-Center, Dose Escalation Phase 1/2 Study of Anti-GM2 Ganglioside Monoclonal Antibody BIW-8962 as Monotherapy in Subjects With Previously Treated Multiple Myeloma', 'orgStudyIdInfo': {'id': 'BIW-8962-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIW-8962, monoclonal antibody', 'interventionNames': ['Drug: BIW-8962']}], 'interventions': [{'name': 'BIW-8962', 'type': 'DRUG', 'otherNames': ['anti GM2 monoclonal antibody'], 'description': 'Intravenous administration of liquid dosage form. Doses 0.03, 0.10, 0.30, 1.0, 3.0, and 10 mg/kg. Frequency is once every two weeks. Duration is 6 months', 'armGroupLabels': ['BIW-8962, monoclonal antibody']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center & Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48201-2014', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Taussig Cancer Center- Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Jeffrey Zonder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karmanos Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kyowa Hakko Kirin Pharma, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}