Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-02-12 @ 1:45 AM
Study NCT ID:
NCT04514159
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2020-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bosnia and Herzegovina']}, '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': 'C000590451', 'term': 'abemaciclib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants will receive the same treatment but ZN-c5 will be given at different doses in this dose escalation study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-11', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events from ZN-c5 in combination with abemaciclib', 'timeFrame': 'Through study completion, anticipated to be 21 months', 'description': 'Measured by the number of treatment-emergent adverse events and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0'}], 'secondaryOutcomes': [{'measure': 'Determine tumor responses to combination treatment', 'timeFrame': 'Through study completion, anticipated to be 21 months', 'description': 'Measured by radiographic responses as defined by revised Response Evaluation Criteria in Solid Tumor (RECIST) v1.1.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dose escalation', 'Phase 1 combination', 'Selective estrogen receptor degrader', 'Hormone sensitive', 'Estrogen receptor', 'Hormone receptor'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in combination with abemaciclib (VERZENIO®) in participants with advanced estrogen-receptor positive, human epidermal growth factor receptor-2 negative (ER+/HER2-) breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Women can be peri- or postmenopausal, as defined by at least one of the following:\n\n * Age ≥ 60 years;\n * Age \\< 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle-stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females;\n * Documented bilateral oophorectomy;\n * Must receive a gonadotrophin-releasing hormone agonist beginning at least 4 weeks prior to the first dose of study medication\n* Histologically or cytologically confirmed diagnosis of advanced adenocarcinoma of the breast\n* Estrogen receptor positive disease\n* Human Epidermal Growth Factor Receptor 2 negative disease\n* Measurable disease per Response Evaluation Criteria in Solid Tumors v1.1\n\nExclusion Criteria:\n\n* Prior therapy within the following windows:\n\n * Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy \\< 14 days;\n * Any investigational drug therapy \\< 28 days or 5 half-lives (whichever is shorter)\n * Any prior systemic chemotherapy regardless of the stop date, but the subject must have recovered to eligibility levels from prior toxicity\n* Prior treatment with CDK4/6 inhibitors\n* Unexplained symptomatic endometrial disorders (including, but not limited to, endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)"}, 'identificationModule': {'nctId': 'NCT04514159', 'briefTitle': 'A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zeno Alpha Inc.'}, 'officialTitle': 'A Phase 1b Study of ZN-c5 in Combination With Abemaciclib in Patients With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'ZN-c5-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ZN-c5 + abemaciclib combination therapy', 'description': 'Participants will take abemaciclib (150mg) orally twice a day and ZN-c5 (dose escalation) orally once or twice a day to determine the safety, tolerability, and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D).', 'interventionNames': ['Drug: ZN-c5', 'Drug: Abemaciclib']}], 'interventions': [{'name': 'ZN-c5', 'type': 'DRUG', 'description': 'ZN-c5 is the study drug.', 'armGroupLabels': ['ZN-c5 + abemaciclib combination therapy']}, {'name': 'Abemaciclib', 'type': 'DRUG', 'otherNames': ['VERZENIO®'], 'description': 'Abemaciclib (VERZENIO®) is an approved drug.', 'armGroupLabels': ['ZN-c5 + abemaciclib combination therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site 2', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Site 1', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '86-300', 'city': 'Grudziądz', 'country': 'Poland', 'facility': 'Site 6', 'geoPoint': {'lat': 53.48411, 'lon': 18.75366}}, {'zip': '30-348', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Site 4', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '93-513', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Site 5', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'overallOfficials': [{'name': 'Carrie Brownstein, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Zeno Alpha Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeno Alpha Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}