Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-25 @ 1:41 PM
Study NCT ID:
NCT07261592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C118739', 'term': 'entinostat'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 29}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-22', 'studyFirstSubmitDate': '2025-11-22', 'studyFirstSubmitQcDate': '2025-11-22', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate, ORR', 'timeFrame': '36 months', 'description': 'ORR refers to the percentage of confirmed cases of complete response (CR) and partial response (PR) according to the RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1.'}], 'secondaryOutcomes': [{'measure': 'ProgressionFree Survival, PFS', 'timeFrame': '36 months', 'description': 'PFS refers to the time from the beginning of treatment to disease progression or death from any reason (whichever occurs first).'}, {'measure': 'Overall Survival, OS', 'timeFrame': '36 months', 'description': 'OS refers to the time from the beginning of treatment to death from any reason.'}, {'measure': 'Disease Control Rate, DCR', 'timeFrame': '36 months', 'description': 'The percentage of cases with CR, PR, and SD (≥4 weeks) among patients with evaluable efficacy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer', 'Histone Deacetylase Inhibitor', 'Entinostat', 'Chemotherapy']}, 'descriptionModule': {'briefSummary': 'This single-center single-arm, open-label prospective clinical trial aimed to evaluate the efficacy and safety of entinostat combined with chemotherapy as second-line therapy for unresectable locally advanced or metastatic bladder cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histopathologic confirmed unresectable advanced or metastatic bladder cancer, except for those with squamous differentiation, glandular differentiation or both;\n* Failure of first-line treatment;\n* There is at least one measurable lesion according to RECIST 1.1;\n* Archived tumor tissue samples or tumor biopsies must be provided;\n* ECOG score of 0-1 an an estimated survival of at least 6 months;\n* Adequate organ function;\n* Patients voluntarily participated in this study, signed the informed consent form, and had good compliance;\n* Women with fertility must consent to contraception during the study and for 6 months after the last dose of study drug.\n\nExclusion Criteria:\n\n* Patients who received platinum-based chemotherapy after failure of first-line treatment;\n* Patients who received platinum-based chemotherapy withnin a 24 month before this trial;\n* Those who have received other anti-tumor treatment or participated in other clinical studies within 4 weeks before the start of the study, or have not recovered from the last toxicity (except grade 2 hair loss and grade 1 neurotoxicity);\n* Concomitant disease such as uncontrolled hypertension or diabetes, renal inadequacy, myocardial infarction, severe angina;\n* Female subjects who are pregnant, breastfeeding or planning to become pregnant during the study;\n* Patients with serious physical or mental illnesses.'}, 'identificationModule': {'nctId': 'NCT07261592', 'briefTitle': 'Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'Entinostat Combined With Chemotherapy as Second-line Therapy for Unresectable Locally Advanced or Metastatic Bladder Cancer: A Single-arm, Prospective Clinical Trial', 'orgStudyIdInfo': {'id': 'IUNU-UC-108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Entinostat plus chemotherapy', 'description': 'The study was divided into two phases: chemotherapy phase and continuous treatment phase. During chemotherapy phase, patients receive 6 cycles of GC (gemcitabine and cisplatin) chemotherapy along with entinostat followed by efficacy evaluation. If stable disease is reached according to RECIST 1.1 criteria, patients may receive continuous entinostat treatment until disease progression or intolerable side effects.', 'interventionNames': ['Drug: Entinostat', 'Drug: Chemotherapy']}], 'interventions': [{'name': 'Entinostat', 'type': 'DRUG', 'description': 'Take entinostat 5mg orally once weekly (at least 1 hour before meal and 2 hours after meal).', 'armGroupLabels': ['Entinostat plus chemotherapy']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'Gisantinib and cisplatin chemotherapy for 6 cycles, 21 days per cycle. Gisantinib 1000mg/m2 is given intravenously on Day 1 and 8 for each cycle while cisplatin 70mg/m2 is given intravenously on Day2.', 'armGroupLabels': ['Entinostat plus chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Junlong Zhuang, PhD', 'role': 'CONTACT', 'email': 'zhuangjl-2008@163.com', 'phone': '15950451917'}, {'name': 'Hongqian Guo, PhD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Hongqian Guo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Hongqian Guo', 'investigatorAffiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}}}}