Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT02391194
Status:
COMPLETED
Last Update Posted:
2017-03-22
First Post:
2015-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-09-21', 'releaseDate': '2018-01-26'}], 'estimatedResultsFirstSubmitDate': '2018-01-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}], '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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-21', 'studyFirstSubmitDate': '2015-02-20', 'studyFirstSubmitQcDate': '2015-03-11', 'lastUpdatePostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of AVB-620 as assessed by the incidence of adverse events and abnormal laboratory values', 'timeFrame': '30 days', 'description': 'The incidence, nature and severity of adverse events and abnormal laboratory values will be collected and analyzed in the evaluation of the safety of AVB-620.'}], 'secondaryOutcomes': [{'measure': 'Characterize the pharmacokinetic profile of AVB-620', 'timeFrame': '8 days', 'description': 'The pharmacokinetics (PK) of AVB-620 will be characterized by collecting and reviewing individual subject plasma concentrations and primary parameters, including clearance, Cmax, Cmin, and distribution.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['AVB-620', 'stage I', 'newly diagnosed', 'breast cancer', 'stage II', 'stage III', 'ductal carcinoma in situ'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, open-label, dose escalation study in women with primary, non-recurrent breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.', 'detailedDescription': 'This study will examine the safety and tolerability of AVB-620 administered as an IV infusion to women with primary, non-recurrent breast cancer undergoing surgery. The study will also characterize the pharmacokinetics of AVB-620 in this subject population and determine the dose of AVB-620 needed to generate a fluorescence signal in tumor and lymph node tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of AVB-620 administration, relative to surgery, on fluorescence characteristics.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ductal carcinoma in situ (DCIS) or Stage I-III, primary invasive carcinoma of the breast\n* Primary surgical treatment is planned to be a mastectomy or lumpectomy. Sentinel lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the subject's therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Adequate renal function\n* Lab values (hematology and chemistry) within institution's normal laboratory limits\n* Willing to remain on-site for approximately 24 hours after administration of AVB-620 or, if required, stay overnight after the surgical procedure\n* If the subject received neoadjuvant therapy, residual tumor is present (to be determined by the primary surgeon)\n* If the subject received prior anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within institution's normal limits\n* Subject has the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Recurrent ipsilateral breast cancer\n* Prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer within 4 weeks before the planned surgery.\n* Open surgery in the ipsilateral breast within 1 year of AVB-620 administration\n* History of radiation therapy to ipsilateral breast\n* Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of AVB-620 administration\n* Diagnosis of autoimmune disorders\n* History of drug-related anaphylactic reactions or allergic reactions; subjects with an active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids will be excluded\n* History of renal disease or current evidence of renal disease\n* Current diagnosis of any other active or clinically significant non-breast cancer\n* Systemic investigational drug of any kind within 6 weeks of AVB-620 administration\n* Pregnant or breast feeding"}, 'identificationModule': {'nctId': 'NCT02391194', 'briefTitle': 'Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avelas Biosciences, Inc.'}, 'officialTitle': 'A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery', 'orgStudyIdInfo': {'id': 'AVB620-C-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AVB-620', 'description': 'Eligible subjects will receive a single dose of AVB-620 as an intravenous infusion before the surgical procedure.', 'interventionNames': ['Drug: AVB-620']}], 'interventions': [{'name': 'AVB-620', 'type': 'DRUG', 'armGroupLabels': ['AVB-620']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Moores UC San Diego Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Hospitals and Clinics', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avelas Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-01-26', 'type': 'RELEASE'}, {'date': '2018-09-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Avelas Biosciences, Inc.'}}}}