Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-01-01 @ 8:45 AM
Study NCT ID:
NCT05209295
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-24
First Post:
2022-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Greece']}, 'conditionBrowseModule': {'meshes': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000709231', 'term': 'cc-486'}, {'id': 'D001374', 'term': 'Azacitidine'}], 'ancestors': [{'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03723135', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2022-01-13', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-t: Estimation of area under the plasma concentration-time curve (AUC) calculated from time zero to the last measured time point', 'timeFrame': 'Day 1'}, {'measure': 'AUC0-∞: Estimation of AUC calculated from time zero to infinity', 'timeFrame': 'Day 1'}, {'measure': 'Cmax: Observed maximum concentration', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 9 Months'}, {'measure': 'Incidence of serious adverse events', 'timeFrame': 'Up to 9 Months'}, {'measure': 'Number of participants with clinically significant changes in electrocardiogram parameters', 'timeFrame': 'Up to 9 Months'}, {'measure': 'Incidence of clinically significant changes in vital signs: Body temperature', 'timeFrame': 'Up to 9 Months'}, {'measure': 'Incidence of clinically significant changes in vital signs: Respiratory rate', 'timeFrame': 'Up to 9 Months'}, {'measure': 'Incidence of clinically significant changes in vital signs: Blood pressure', 'timeFrame': 'Up to 9 Months'}, {'measure': 'Incidence of clinically significant changes in vital signs: Heart rate', 'timeFrame': 'Up to 9 Months'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Hematology tests', 'timeFrame': 'Up to 9 Months'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests', 'timeFrame': 'Up to 9 Months'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests', 'timeFrame': 'Up to 9 Months'}, {'measure': 'Number of Participants with clinically significant changes in Eastern Cooperative Oncology Group (ECOG) performance status', 'timeFrame': 'Up to 9 Months'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Liver Function tests', 'timeFrame': 'Up to 9 Months'}, {'measure': 'Number of clinically significant changes in physical examinations', 'timeFrame': 'Up to 9 Months'}, {'measure': 'Number of participants with a recording of concomitant medications', 'timeFrame': 'Up to 9 Months'}, {'measure': 'Number of participants with a recording of concomitant procedures', 'timeFrame': 'Up to 9 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CC-486', 'Azacitidine', 'Hepatic Impairment', 'Onureg', 'Myeloid Malignancies'], 'conditions': ['Hepatic Insufficiency', 'Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of moderate or severe liver impairment on the drug levels of oral azacitidine and the safety and tolerability of oral azacitidine in participants with myeloid malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diagnosis of Myelodysplastic syndrome, Acute myeloid leukemia, Non-acute promyelocytic leukemia, Chronic myelomonocytic leukemia, Philadelphia-negative myeloproliferative neoplasms, Myelodysplastic syndrome Myeloproliferative neoplasms overlap, Accelerated phase and blast phase Myeloproliferative neoplasms, Blastic plasmacytoid dendritic cell neoplasm according to the World Health Organization (WHO) 2016 classification\n* Life expectancy of ≥ 3 months\n* Stable renal function without dialysis for at least 2 months prior to investigational product administration\n* Has moderate or severe hepatic impairment as defined by National Cancer Institute Organ Dysfunction Working Group criteria\n\nExclusion Criteria:\n\n* Chemotherapy or radiotherapy within 2 weeks or 5 half-lives, whichever is longer, prior to the first day of investigational product administration\n* Persistent, clinically significant non-hematologic toxicities from prior therapies which have not recovered to \\< Grade 2\n* Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study\n* History of inflammatory bowel disease, celiac disease, prior gastrectomy, gastric bypass, upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption of the investigational product and/or predispose the participant to an increased risk of gastrointestinal toxicity\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT05209295', 'briefTitle': 'A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, Multicenter, Open-label Study to Evaluate the Pharmacokinetics of CC-486 (Onureg®) in Subjects With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Adult Subjects With Myeloid Malignancies', 'orgStudyIdInfo': {'id': 'CA055-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'interventionNames': ['Drug: Onureg']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'interventionNames': ['Drug: Onureg']}, {'type': 'OTHER', 'label': 'Group 3', 'description': 'Control - participants with normal hepatic function', 'interventionNames': ['Drug: Onureg']}], 'interventions': [{'name': 'Onureg', 'type': 'DRUG', 'otherNames': ['CC-486, Oral Azacitidine'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Local Institution - 0083', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Local Institution - 0069', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Local Institution - 9003', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '1629', 'city': 'Pilar', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Local Institution - 0011', 'geoPoint': {'lat': -34.45867, 'lon': -58.91398}}, {'zip': 'C1199ABB', 'city': 'ABB', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Local Institution - 0010'}, {'zip': 'C1118AAT', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'country': 'Argentina', 'facility': 'Local Institution - 0014', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1426', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Local Institution - 0012', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '110131', 'city': 'Bogotá', 'state': 'Bogota D.C.', 'country': 'Colombia', 'facility': 'Local Institution - 0085', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '111151', 'city': 'Bogota', 'state': 'Cundinamarca', 'country': 'Colombia', 'facility': 'Local Institution - 0084'}, {'zip': '681017', 'city': 'Piedecuesta', 'state': 'Santander Department', 'country': 'Colombia', 'facility': 'Local Institution - 0086', 'geoPoint': {'lat': 6.98789, 'lon': -73.04953}}, {'zip': '86156', 'city': 'Augsburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Local Institution - 0076', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '06120', 'city': 'Halle', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'Local Institution - 0075', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Local Institution - 0074', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona [Barcelona]', 'country': 'Spain', 'facility': 'Local Institution - 0018', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona [Barcelona]', 'country': 'Spain', 'facility': 'Local Institution - 0017', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Local Institution - 0015', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Local Institution - 0078', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}