Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-28 @ 1:42 PM
Study NCT ID:
NCT00522457
Status:
TERMINATED
Last Update Posted:
2011-04-29
First Post:
2007-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy
Sponsor:
Organization:
Raw JSON
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Prior to any submission for publication, presentation, or communication of results or information arising from the Study, Investigator shall provide Fresenius Biotech at least 90 days for review and comment upon the manuscript or other material for such publication or presentation.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "The study was prematurely terminated. This decision was based on strategic changes in the company's research and development program and resulted in limited patient data."}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ertumaxomab', 'otherNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 27, 'numAffected': 14}], 'organSystem': 'General disorders'}, {'term': 'pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 28, 'numAffected': 13}], 'organSystem': 'General disorders'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'General disorders'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 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QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'myalgia', 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'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertumaxomab'}], 'paramType': 'NUMBER', 'timeFrame': 'patients are monitored for 6 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated, therefore no participants were analyzed. The primary endpoint was the objective response rate (ORR) to ertumaxomab (best response during the course of the study), defined as the number of patients with CR or PR according to RECIST, relative to the total population of treated patients'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertumaxomab'}], 'paramType': 'NUMBER', 'timeFrame': 'patients are monitored for 6 months', 'description': 'The study was prematurely terminated, therefore no participants were analyzed', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated, therefore no participants were analyzed'}, {'type': 'SECONDARY', 'title': 'Clinical Benefit Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertumaxomab'}], 'paramType': 'NUMBER', 'timeFrame': 'patients are monitored for 6 months', 'description': 'The study was prematurely terminated, therefore no participants were analyzed', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was prematurely terminated, therefore no participants were analyzed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ertumaxomab'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Due to disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Open-label phase 2 study evaluating the efficacy and safety of ertumaxomab for the treatment of metastatic breast cancer tumors. Ertumaxomab will be administered 3 times at 7 day intervals by constant rate 3 hour intravenous (IV) infusions according to the following dose schedule: 10 µg (day 0); 100 µg (day 7±1)and 100 µg(day14±1)(flat doses).', 'preAssignmentDetails': 'Patients were required to complete screening procedures and up to five treatment visits.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ertumaxomab'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'change in development plan, not due to safety concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-28', 'studyFirstSubmitDate': '2007-08-28', 'resultsFirstSubmitDate': '2011-03-01', 'studyFirstSubmitQcDate': '2007-08-28', 'lastUpdatePostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-04-28', 'studyFirstPostDateStruct': {'date': '2007-08-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Efficacy Measured by Objective Response Rate (Best Response During the Course of the Study)', 'timeFrame': 'patients are monitored for 6 months'}], 'secondaryOutcomes': [{'measure': 'Duration of Response', 'timeFrame': 'patients are monitored for 6 months', 'description': 'The study was prematurely terminated, therefore no participants were analyzed'}, {'measure': 'Clinical Benefit Rate', 'timeFrame': 'patients are monitored for 6 months', 'description': 'The study was prematurely terminated, therefore no participants were analyzed'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast Cancer', 'investigational drug', 'drug therapy', 'Antineoplastic Protocols', 'Immunotherapy', 'Metastatic breast cancer', 'Advanced breast cancer', 'Stage IV breast cancer', 'Her-2/neu expressing breast cancer', 'Her-2/neu', 'Trastuzumab refractory'], 'conditions': ['Metastatic Breast Cancer', 'Advanced Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '16707606', 'type': 'BACKGROUND', 'citation': 'Kiewe P, Hasmuller S, Kahlert S, Heinrigs M, Rack B, Marme A, Korfel A, Jager M, Lindhofer H, Sommer H, Thiel E, Untch M. Phase I trial of the trifunctional anti-HER2 x anti-CD3 antibody ertumaxomab in metastatic breast cancer. Clin Cancer Res. 2006 May 15;12(10):3085-91. doi: 10.1158/1078-0432.CCR-05-2436.'}, {'pmid': '11588051', 'type': 'BACKGROUND', 'citation': 'Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34. doi: 10.1182/blood.v98.8.2526.'}, {'pmid': '11410615', 'type': 'BACKGROUND', 'citation': 'Riesenberg R, Buchner A, Pohla H, Lindhofer H. Lysis of prostate carcinoma cells by trifunctional bispecific antibodies (alpha EpCAM x alpha CD3). J Histochem Cytochem. 2001 Jul;49(7):911-7. doi: 10.1177/002215540104900711.'}, {'pmid': '10901380', 'type': 'BACKGROUND', 'citation': 'Zeidler R, Mysliwietz J, Csanady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6. doi: 10.1054/bjoc.2000.1237.'}, {'pmid': '10415020', 'type': 'BACKGROUND', 'citation': 'Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.'}]}, 'descriptionModule': {'briefSummary': 'This study has the purpose to demonstrate clinical efficacy of the investigational new drug ertumaxomab in patients with human epidermal growth factor receptor-2 (HER-2/neu) overexpressing (3+ or 2+ with a positive Fluorescence In Situ Hybridization (FISH) test result) metastatic breast cancer progressing after trastuzumab treatment.\n\nErtumaxomab is a trifunctional bispecific antibody targeting Her-2/neu on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory immune effector cells (e.g. macrophages, dendritic cells \\[DCs\\] and natural killer \\[NK\\] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these immune cells, which can trigger a complex anti-tumor immune response.', 'detailedDescription': 'This study is an open-label, non-randomized, uncontrolled, two-stage phase II study evaluating the efficacy and safety of ertumaxomab. Ertumaxomab will be administered three times at 7 day intervals by constant rate 3 hour intravenous (i.v.) infusions according to the following dose schedule: 10 µg (day 0); 100 µg (day 7 ± 1 day) and 100 µg (day 14 ± 1 day) (flat doses).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Women ≥ 18 years, Negative pregnancy test at screening and life expectancy of at least 3 months\n* metastatic (stage IV) and not curable adenocarcinoma of the breast\n* Measurable disease, defined as at least one lesion that is measurable in one dimension (RECIST)\n* HER-2 overexpression 3+ or 2+ FISH positive\n* Patients must have received one prior therapy with trastuzumab as last treatment before entry into the study. If trastuzumab was given as single agent treatment, patients must have received prior chemotherapy for metastatic disease\n* Trastuzumab has been discontinued before study entry\n* disease had progressed during or after trastuzumab therapy\n* Eastern Cooperative Oncology Group (ECOG)performance score of ≤ 2\n* Adequate hematological, liver and kidney function\n\nKey Exclusion Criteria:\n\n* Women who are pregnant or breast feeding\n* Any history or symptoms indicative of brain or central nervous system metastases\n* Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)\n* Human anti-murine antibody positive or hypersensitivity to murine proteins and any other component of the study drug\n* Known autoimmune diseases, Human immunodeficiency virus (HIV), hepatitis B or C infection as well as other acute or chronic infection or other concurrent non-malignant co-morbidities that are uncontrolled\n* Any concurrent chemotherapy, hormonal therapy, immunotherapy or corticoid therapy\n* Concurrent antibiotic treatment\n* Any concurrent investigational treatment for metastatic disease\n\nCardiovascular exclusion criteria:\n\n* Unstable or uncontrolled pectorial angina\n* Myocardial infarction during the last 6 months\n* Valvular heart disease that requires treatment\n* Cardiomyopathy (congestive, hypertrophic or restrictive)\n* Acute myocarditis\n* Congestive heart failure (CHF): dyspnea, clinically or radiologically diagnosed\n* Left ventricular ejection fraction (LVEF)outside institution's normal range based on echocardiography at rest\n* Left ventricular diameter \\> 56 mm based on M-mode echocardiography at rest\n* Arrhythmias that require treatment (atrioventricular block II/III degree, atrial fibrillation, ventricular tachycardia)\n* Poorly or uncontrolled hypertension, asthma, seizures, allergies, pulmonary dysfunction"}, 'identificationModule': {'nctId': 'NCT00522457', 'briefTitle': 'Phase II Study With the Trifunctional Antibody Ertumaxomab to Treat Metastatic Breast Cancer After Progression on Trastuzumab Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neovii Biotech'}, 'officialTitle': 'Phase II Study Of The Trifunctional Bispecific Anti-HER-2/Neu x Anti-CD3 Antibody Ertumaxomab In Patients With HER-2/Neu Overexpressing (3+ Or 2+/FISH+) Metastatic Breast Cancer Progressing After Trastuzumab Treatment', 'orgStudyIdInfo': {'id': 'IV-ERT-BC-04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ertumaxomab', 'type': 'DRUG', 'description': "Ertumaxomab will be intravenously administered to see if it can increase the patient's objective response rate."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Gary Schwartz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center; Lebanon, NH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neovii Biotech', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fresenius Biotech North America', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Manager of Regulatory Affairs', 'oldOrganization': 'Fresenius Biotech North America'}}}}