Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-03-11 @ 9:09 PM
Study NCT ID:
NCT03244358
Status:
TERMINATED
Last Update Posted:
2021-01-29
First Post:
2017-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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': 'C038131', 'term': 'epalrestat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Difficulty accruing subjects the study accrual was closed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2017-07-23', 'studyFirstSubmitQcDate': '2017-08-08', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': '30 months', 'description': 'the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': '30 months', 'description': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0'}, {'measure': 'Overall Survival', 'timeFrame': '3 years', 'description': 'OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Triple Negative Breast Cancer', 'Epalrestat'], 'conditions': ['Triple Negative Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of Epalrestat in the treatment of metastatic triple negative breast', 'detailedDescription': 'This is a phase II,single center,prospective, single arm clinical trials. The objective is to evaluate the efficacy and safetyof Epalrestat in the treatment of metastatic triple negative breast.Primary endpoint is 16-week clinical benefit rate (CBR).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female ≥ 18 years, ≤70 years.\n* Minimum life expectancy 16 weeks\n* Histologicalconfirmation of hormone receptor negative and HER2 negative breast cancer(IHC:ER -, PR-) on primary tumour at diagnosis/on biopsy of metastasis\n* Clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection\n* ECOG 0-2 with no deterioration over previous 2 weeks Measurable disease\n* Adequate bone marrow and organ function\n* Availability of archival tumour sample or fresh biopsy Informed consent\n* Normal organ function\n\nExclusion Criteria:\n\n* Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour embolisation \\<21 days prior to study treatment\n* Last dose of palliative radiotherapy \\<7 days prior to study treatment\n* Rapidly progressive visceral disease not suitable for further therapy\n* Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and stable and not requiring steroids for ≥ 4 weeks study treatment\n* Major surgery (excluding placement of vascular access) within 4 weeks before study treatment\n* Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV\n* With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment\n* Elevated ALP in absence of bone metastasis\n* Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent\n* Participation in another study with investigational product during last 30 days\n* Inability or unwillingness to comply with study procedures, including inability to take regular oral medication'}, 'identificationModule': {'nctId': 'NCT03244358', 'briefTitle': 'Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer:A Single Arm,Single Center,Phase II Study', 'orgStudyIdInfo': {'id': 'SYSUCC-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epalrestat', 'description': 'Epalrestat added to standard treatment', 'interventionNames': ['Drug: Epalrestat']}], 'interventions': [{'name': 'Epalrestat', 'type': 'DRUG', 'otherNames': ['Tanglin (Yangtze River Pharmaceutical Group), China'], 'description': 'Epalrestat 50mg tid added to standard chemotherapy treatment', 'armGroupLabels': ['Epalrestat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University, Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'zhongyu yuan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professer', 'investigatorFullName': 'Zhong-yu Yuan', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}