Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-25 @ 2:41 AM
Study NCT ID:
NCT03316794
Status:
TERMINATED
Last Update Posted:
2018-12-17
First Post:
2017-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Strategic considerations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-14', 'studyFirstSubmitDate': '2017-10-18', 'studyFirstSubmitQcDate': '2017-10-18', 'lastUpdatePostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Dose-limiting Toxicities (DLTs)', 'timeFrame': 'Minimum 21 days', 'description': "DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03."}], 'secondaryOutcomes': [{'measure': 'QTcF Change from Baseline', 'timeFrame': 'Up to approximately 9 weeks', 'description': "QT interval measurement corrected by Fridericia's formula (QTcF)"}, {'measure': 'Area Under the Plasma Concentration-time Curve (AUC)', 'timeFrame': 'Up to approximately 9 weeks', 'description': 'Area under the plasma concentration-time curve (AUC) of SC-005.'}, {'measure': 'Clinical benefit rate (CBR)', 'timeFrame': 'Up to approximately 4 years', 'description': 'CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR +SD).'}, {'measure': 'Maximum plasma concentration observed (Cmax)', 'timeFrame': 'Up to approximately 9 weeks', 'description': 'Maximum plasma concentration observed (Cmax) of SC-005'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 4 years', 'description': "OS is defined as the time from the participant's first dose date to death due to any cause."}, {'measure': 'Observed Plasma Concentrations at Trough', 'timeFrame': 'Up to approximately 9 weeks', 'description': 'Observed plasma concentrations at trough of SC-005.'}, {'measure': 'Duration of Clinical Benefit (DOCB)', 'timeFrame': 'Up to approximately 4 years', 'description': "DOCB is defined as the time from the participant's initial observation of clinical benefit (CR or PR or stable disease \\[SD\\]) to PD or death due to any cause, whichever occurs first."}, {'measure': 'Objective Response Rate (ORR)Up to approximately 4 years', 'timeFrame': 'Up to approximately 4 years', 'description': 'Objective response rate is defined as the proportion of participants with complete response (CR) or partial response (PR) based on RECIST version 1.1.'}, {'measure': 'Time of Cmax (Tmax)', 'timeFrame': 'Up to approximately 9 weeks', 'description': 'Time of Cmax (Tmax) of SC-005.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to approximately 4 years', 'description': "PFS time is defined as the time from the participant's first dose of study drug (Day 1) to either the participant's disease progression or death due to any cause."}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 4 years', 'description': 'DOR is defined as the time from the participants initial objective response (CR or PR) to disease progression (PD) or death due to any cause, whichever occurs first.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Triple Negative Breast Cancer', 'Cancer', 'Breast Cancer', 'Maximum tolerated dose (MTD)', 'Pharmacokinetics'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label study in participants with triple negative breast cancer (TNBC) to study the safety, tolerability, pharmacokinetics and preliminary efficacy of SC-005. This study consists of 2 parts: Part A (dose regimen finding) followed by Part B (dose expansion).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced TNBC that is relapsed, refractory, or progressive and not eligible for another standard therapy that would confer clinical benefit to the subject.\n\n * Advanced disease is defined as metastatic disease or locally advanced disease that is not amenable to surgery or radiotherapy with curative intent\n * TNBC is defined as:\n* \\<1% staining by immunohistochemistry (IHC) for estrogen (ER) and progesterone (PR) receptors, 0 or 1+ IHC for human epidermal growth factor receptor 2 (HER2), OR\n* Negative for HER2 amplification by in situ hybridization (ISH) for 2+ IHC disease.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, hepatic, and renal function.\n\nExclusion Criteria:\n\n* Any significant medical condition including any suggested by Screening laboratory findings that, in the opinion of the Investigator or Sponsor, may place the subject at undue risk from the study.\n* Has ECG abnormalities that make QT interval corrected (QTc) evaluation difficult (e.g., severe morphologic abnormalities).\n* Prior exposure to a pyrrolobenzodiazepine or indolino-benzodiazepine based drug, or known hypersensitivity or contraindication to SC-005 or excipient contained in the drug formulation.'}, 'identificationModule': {'nctId': 'NCT03316794', 'briefTitle': 'A Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'An Open-Label Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)', 'orgStudyIdInfo': {'id': 'M16-735'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SC-005', 'description': 'SC-005 intravenous (IV) (various doses and dose regimens)', 'interventionNames': ['Drug: SC-005']}], 'interventions': [{'name': 'SC-005', 'type': 'DRUG', 'description': 'intravenous', 'armGroupLabels': ['SC-005']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637-1443', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago /ID# 169231', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School /ID# 169177', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering /ID# 201016', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Gabrail Cancer Center Research /ID# 168756', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma University /ID# 200937', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology-Sarah Cannon Research Institute /ID# 169233', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor University /ID# 169860', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center /ID# 169232', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}