Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-01 @ 10:45 PM
Study NCT ID:
NCT02623751
Status:
COMPLETED
Last Update Posted:
2022-06-21
First Post:
2015-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of KHK2375 in Subjects With Advanced or Recurrent 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': 'C056516', 'term': 'exemestane'}, {'id': 'C118739', 'term': 'entinostat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-15', 'studyFirstSubmitDate': '2015-11-18', 'studyFirstSubmitQcDate': '2015-12-03', 'lastUpdatePostDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and percentage of subjects with treatment-emergent adverse events including dose-limiting toxicities and serious adverse events', 'timeFrame': 'Assessed up to 28 days after study discontinuation'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of KHK2375 [maximum concentration (Cmax)]', 'timeFrame': 'Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1'}, {'measure': 'Pharmacokinetics of KHK2375 [Area under the curve (AUC)]', 'timeFrame': 'Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1'}, {'measure': 'Pharmacokinetics of KHK2375 [Half-life (t1/2)]', 'timeFrame': 'Pre-dose, Cycle 0 Days 1, 2, 4, 6, Cycle 1 Days 1, 2, 4, 6, 8, 15, 22 and Cycle 2 Day 1'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '34819039', 'type': 'DERIVED', 'citation': 'Masuda N, Tamura K, Yasojima H, Shimomura A, Sawaki M, Lee MJ, Yuno A, Trepel J, Kimura R, Nishimura Y, Saji S, Iwata H. Phase 1 trial of entinostat as monotherapy and combined with exemestane in Japanese patients with hormone receptor-positive advanced breast cancer. BMC Cancer. 2021 Nov 24;21(1):1269. doi: 10.1186/s12885-021-08973-4.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the open-label, dose-escalation study is to investigate the safety of single-dose monotherapy and repeated-dose of KHK2375 combined with exemestane in female subjects with advanced or recurrent breast cancer. The secondary objective is to investigate the pharmacokinetics and efficacy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women aged ≥ 20 and \\< 75 years at the time of consent;\n* Estrogen receptor positive and/or progesterone receptors positive;\n* HER2-negative\n* Nonresectable advanced or recurrent breast cancer previously treated with nonsteroidal aromatase inhibitor (AI), and planning to be treated with exemestane\n\nExclusion Criteria:\n\n* Radiation therapy or immuno therapy within 14 days before the first dose of investigational product;\n* Chemotherapy, biological medicines, other pharmacotherapy or major surgery within 21 days before the first dose of the investigational product;\n* Prior chemotherapies of ≥ 3 regimens for advanced or recurrent breast cancer;\n* Ongoing treatment with other investigational product'}, 'identificationModule': {'nctId': 'NCT02623751', 'briefTitle': 'Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'Phase 1 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer', 'orgStudyIdInfo': {'id': '2375-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KHK2375 PO and Exemestane PO', 'description': 'KHK2375 and Exemestane', 'interventionNames': ['Drug: KHK2375', 'Drug: Exemestane']}], 'interventions': [{'name': 'KHK2375', 'type': 'DRUG', 'description': 'KHK2375 will be orally administered once weekly. KHK2375 in combination with exemestane will be repeatedly administered in a 28-day cycle.\n\nExemestane will be orally administered once daily.', 'armGroupLabels': ['KHK2375 PO and Exemestane PO']}, {'name': 'Exemestane', 'type': 'DRUG', 'otherNames': ['Entinostat', 'MS-275', 'SDNX-275'], 'description': 'KHK2375 will be orally administered once weekly. KHK2375 in combination with exemestane will be repeatedly administered in a 28-day cycle.\n\nExemestane will be orally administered once daily.', 'armGroupLabels': ['KHK2375 PO and Exemestane PO']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chikusa-ku', 'state': 'Aichi-ken', 'country': 'Japan'}, {'city': 'Chuo-ku', 'state': 'Osaka', 'country': 'Japan'}, {'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}