Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT00704158
Status:
COMPLETED
Last Update Posted:
2015-02-19
First Post:
2008-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C541991', 'term': 'CR011-vcMMAE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'dispFirstSubmitDate': '2015-02-02', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-02', 'studyFirstSubmitDate': '2008-06-23', 'dispFirstSubmitQcDate': '2015-02-02', 'studyFirstSubmitQcDate': '2008-06-23', 'dispFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of CR011-vcMMAE in breast cancer patients', 'timeFrame': 'throughout the study'}, {'measure': 'To determine the MTD of CR011-vcMMAE in breast cancer patients', 'timeFrame': 'throughout the study'}], 'secondaryOutcomes': [{'measure': 'Evaluation of efficacy (progression-free survival rate at 12 weeks, objective response rate, time to response, duration of response and time to progression)', 'timeFrame': 'throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CR011-vcMMAE', 'locally advanced breast cancer', 'metastatic breast cancer', 'breast cancer', 'CuraGen'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '25267761', 'type': 'RESULT', 'citation': 'Bendell J, Saleh M, Rose AA, Siegel PM, Hart L, Sirpal S, Jones S, Green J, Crowley E, Simantov R, Keler T, Davis T, Vahdat L. Phase I/II study of the antibody-drug conjugate glembatumumab vedotin in patients with locally advanced or metastatic breast cancer. J Clin Oncol. 2014 Nov 10;32(32):3619-25. doi: 10.1200/JCO.2013.52.5683. Epub 2014 Sep 29.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/25267761', 'label': 'Phase I/II study of the antibody-drug conjugate glembatumumab vedotin in patients with locally advanced or metastatic breast cancer.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and tolerability of CR011-vcMMAE in patients with locally advanced and metastatic breast cancer. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks (q3w) to cohorts of 3-6 patients to confirm the maximum tolerated dose (MTD) in breast cancer patients. Once the MTD is confirmed, up to 25 patients with locally advanced or metastatic breast cancer will be enrolled into the Phase II portion of the trial to further evaluate the safety and efficacy of CR011-vcMMAE.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Females with confirmed breast cancer\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2\n* Locally advanced or metastatic disease who have received at least two prior chemotherapeutic regimens for breast cancer, as follows:\n\n * At least one regimen must have been for locally advanced or metastatic disease\n * Subject must have received an anthracycline, a taxane, and capecitabine in any combination unless the subject was intolerant to or not a candidate for any of these agents\n * Hormonal therapy, biologic therapy (such as trastuzumab or bevacizumab), or immunotherapy do not count as one of the 2 regimens\n * Subjects with HER2/neu overexpressing tumors must have been treated with trastuzumab except in situations where the subject was intolerant to or not a candidate for trastuzumab\n* Documented progressive disease within 6 months of the last regimen\n* Adequate bone marrow, renal and liver function\n* Signed informed consent\n\nMain Exclusion Criteria:\n\n* Chemotherapy, radiation, hormonal therapy, or bevacizumab within two weeks, or trastuzumab or investigational therapy within three weeks before treatment start\n* Neuropathy \\> NCI-CTCAE Grade 1\n* Active brain metastases.\n* New York Heart Association class III or IV heart disease\n* Unstable angina\n* Uncontrolled arrhythmia\n* A marked baseline prolongation of QT/QTc interval\n* Pregnant or breast-feeding women, and women of childbearing age and potential who are not willing to use effective contraception'}, 'identificationModule': {'nctId': 'NCT00704158', 'briefTitle': 'Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celldex Therapeutics'}, 'officialTitle': 'A Phase I/II Study of CR011-vcMMAE in Patients With Locally Advanced or Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'CR011-CLN-20'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CR011-vcMMAE', 'type': 'DRUG', 'description': 'administered as an intravenous infusion on Day 1 of a 21 day cycle.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33916', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33461', 'city': 'Lake Worth', 'state': 'Florida', 'country': 'United States', 'facility': 'Hematology Oncology Associates', 'geoPoint': {'lat': 26.61708, 'lon': -80.07231}}, {'zip': '30341', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Cancer Specialists', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Cornell University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CuraGen Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}