Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
Study NCT ID:
NCT06091267
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-26
First Post:
2023-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077209', 'term': 'Decitabine'}, {'id': 'C000723076', 'term': 'decitabine and cedazuridine drug combination'}, {'id': 'C000633944', 'term': 'cedazuridine'}], 'ancestors': [{'id': 'D001374', 'term': 'Azacitidine'}, {'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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2023-09-22', 'studyFirstSubmitQcDate': '2023-10-12', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Response Rate', 'timeFrame': 'An analysis is planned when the last enrolled patient have completed Follow-up 12 months.', 'description': 'Assess efficacy \\[Complete Response Rate (CR)\\] of treatment with ASTX727 in Chinese subjects with myelodysplastic syndromes (MDS);'}, {'measure': '5day_AUC0-τ', 'timeFrame': 'An analysis is planned when the last enrolled patient have completed the treatment with ASTX727 (oral) versus decitabine for IV infusion for 5 day.', 'description': 'Assess pharmacokinetic (PK) parameters (Total 5-day AUC exposures of decitabine) after treatment with ASTX727 (oral) versus decitabine for IV infusion for 5 days;'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Objective Response Rate (ORR): The proportion of subjects who achieve CR and partial response (PR) based on IWG 2006 criteria;'}, {'measure': 'Clinical Response Rate', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Clinical Response Rate: The proportion of subjects who achieve CR, PR, marrow complete response (mCR), and hematologic improvement (HI) based on IWG 2006 criteria.'}, {'measure': 'Rate of transfusion independence', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Rate of transfusion independence: The proportion of subjects who had no blood transfusion of 2 or more units of PRBCs for 56 days or more after treatment;'}, {'measure': 'disease progression', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Time to progression to acute myeloid leukemia (AML);'}, {'measure': 'Overall survival', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Overall survival (OS).'}, {'measure': 'Safety assessment', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Safety as assessed by adverse events (AEs), concomitant medications, physical examination, clinical laboratory tests (hematology , serum chemistry and urinalysis), vital signs, Eastern Cooperative Oncology Group (ECOG) performance status, and electrocardiogram (ECG).'}, {'measure': 'peak concentration (Cmax)', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Decitabine PK parameters: peak concentration (Cmax).'}, {'measure': 'time to peak concentration (Tmax)', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Decitabine PK parameters: time to peak concentration (Tmax).'}, {'measure': 'area under the plasma concentration-time curve over a dosing interval (AUC0-τ).', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Decitabine PK parameters: area under the plasma concentration-time curve over a dosing interval (AUC0-τ).'}, {'measure': 'accumulation ratio based on AUC0-τ (Rac_AUC0-τ).', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Decitabine PK parameters: accumulation ratio based on AUC0-τ (Rac\\_AUC0-τ).'}, {'measure': 'accumulation ratio based on Cmax (Rac_Cmax).', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'Decitabine PK parameters: accumulation ratio based on Cmax (Rac\\_Cmax).'}, {'measure': 'Cmax', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'PK parameters of E7727 and E7727-epimer: Cmax.'}, {'measure': 'Tmax', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'PK parameters of E7727 and E7727-epimer: Tmax.'}, {'measure': 'AUC0-τ', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'PK parameters of E7727 and E7727-epimer: area under the plasma concentration-time curve over a dosing interval .'}, {'measure': 'Rac_AUC0-τ', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'PK parameters of E7727 and E7727-epimer: accumulation ratio based on AUC0-τ.'}, {'measure': 'Rac_Cmax', 'timeFrame': 'through study completion, an average of 1 year.', 'description': 'PK parameters of E7727 and E7727-epimer: accumulation ratio based on Cmax.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'This is an Open-Label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 versus IV Decitabine in Chinese Subjects with Myelodysplastic Syndromes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Agree to participate in this trial and voluntarily sign the informed consent form.\n2. Men or women ≥ 18 years at the time of signing the informed consent form.\n3. Subjects with MDS previously treated or untreated with de novo or secondary MDS.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening.\n\nExclusion Criteria:\n\n1. Prior treatment with more than 1 cycle of azacitidine or decitabine.\n2. Cytotoxic chemotherapy or prior azacitidine or decitabine within 4 weeks of first dose of study treatment.\n3. Conditions as judged by the investigator to be inappropriate for participation in the clinical trial.\n4. Previous diagnosis of malignant tumor.\n5. History of immune deficiency.\n6. Acute myeloid leukemia (AML) with bone marrow or peripheral blast count ≥ 20% or other malignant hematological diseases.'}, 'identificationModule': {'nctId': 'NCT06091267', 'briefTitle': 'PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Beijing Research Institute'}, 'officialTitle': 'An Open-label, Crossover, Pharmacokinetic and Efficacy Bridging Study of Oral ASTX727 Versus IV Decitabine in Chinese Subjects With Myelodysplastic Syndromes', 'orgStudyIdInfo': {'id': '393-403-00072'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASTX727 and IV Decitabine', 'description': 'Cycle1：ASTX727 tablets, oral, 1 tablet/day for 5 days；Cycle2：IV Decitabine, 20 mg/m\\^2, is administered for 1 hour at a time for 5 days；≥ Cycle 3：ASTX727 tablets, oral, 1 tablet/day for 5 days', 'interventionNames': ['Drug: IV Decitabine', 'Drug: Decitabine and cedazuridine', 'Drug: only Decitabine and cedazuridine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV Decitabine and ASTX727', 'description': 'Cycle1：IV Decitabine, 20 mg/m\\^2, is administered for 1 hour at a time for 5 days； Cycle2：ASTX727 tablets, oral, 1 tablet/day for 5 days；≥ Cycle 3：ASTX727 tablets, oral, 1 tablet/day for 5 days', 'interventionNames': ['Drug: IV Decitabine', 'Drug: Decitabine and cedazuridine', 'Drug: only Decitabine and cedazuridine']}, {'type': 'EXPERIMENTAL', 'label': 'ASTX727', 'description': 'ASTX727 tablets, oral, 1 tablet/day for 5 days；', 'interventionNames': ['Drug: only Decitabine and cedazuridine']}], 'interventions': [{'name': 'IV Decitabine', 'type': 'DRUG', 'description': 'The subjects will receive decitabine 20 mg/m\\^2 IV daily × 5 days in 28-day cycles.', 'armGroupLabels': ['ASTX727 and IV Decitabine', 'IV Decitabine and ASTX727']}, {'name': 'Decitabine and cedazuridine', 'type': 'DRUG', 'description': 'subjects will receive treatment with ASTX727, 1 tablet/day for 5 consecutive days, in 28-day cycles.', 'armGroupLabels': ['ASTX727 and IV Decitabine', 'IV Decitabine and ASTX727']}, {'name': 'only Decitabine and cedazuridine', 'type': 'DRUG', 'description': 'subjects will receive treatment with ASTX727, 1 tablet/day for 5 consecutive days, in 28-day cycles, until disease progression, unacceptable toxicity, or the subject/investigator decides that the subject should discontinue treatment or withdraw from the trial.', 'armGroupLabels': ['ASTX727', 'ASTX727 and IV Decitabine', 'IV Decitabine and ASTX727']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital,Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Beijing Research Institute', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}