Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-03 @ 12:57 AM
Study NCT ID:
NCT03934567
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-10
First Post:
2019-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C512352', 'term': 'abexinostat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2019-04-29', 'studyFirstSubmitQcDate': '2019-04-30', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical effect of abexinostat on objective response rate as assessed by an independent central imaging review', 'timeFrame': 'up to 56 days', 'description': 'Objective response rate (ORR), defined as the proportion of patients who have completed response (CR) or partial response (PR) as assessed by an Independent Central Imaging Review'}], 'secondaryOutcomes': [{'measure': 'Objective Response', 'timeFrame': 'up to 56 days', 'description': 'Objective response rate (ORR) as assessed by the investigator'}, {'measure': 'Progression-free survival', 'timeFrame': 'Up to 2 years', 'description': 'Progression-free survival (PFS), defined as the time from the initiation of treatment to disease progression or death as assessed by the Independent Central Imaging Review and the investigator'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['refractory', 'relapsed', 'lymph nodes'], 'conditions': ['Lymphoma, Follicular']}, 'descriptionModule': {'briefSummary': 'An open-label, single-arm, multi-center phase 2 study to evaluate the efficacy and safety of oral histone deacetylase (HDAC)-inhibitor abexinostat, as monotherapy in patients with relapsed or refractory follicular lymphoma (FL)', 'detailedDescription': 'This is an open-label, single-arm, two-stage, multi-center, phase 2 study in patients with relapsed/refractory follicular lymphoma (FL) who have received at least two prior standard therapy lines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Life expectancy ≥ 3 months\n2. Histologically confirmed grade 1, 2, or 3a follicular lymphoma (FL)\n3. Have received at least two prior standard therapy lines including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy for follicular lymphoma (FL)\n4. Confirmed to be unresponsive to the last line of therapy (have stable disease or disease progression during treatment),or have disease progression following the last line of therapy\n5. Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion as assessed by computed tomography (CT) or magnetic resonance imaging (MRI);\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n7. Meet various hematological, liver function and renal function lab parameters\n\nExclusion Criteria:\n\n1. Histologically confirmed grade 3b follicular lymphoma, or transformed diffuse large B-cell lymphoma (DLBCL)\n2. Current or history of central nervous system (CNS) lymphoma;\n3. Toxicity not yet recovered from previous anti-tumor therapies\n4. Uncontrolled systemic infections or infections requiring intravenous antibiotics\n5. Have previously treated by abexinostat or other histone deacetylase (HDAC) inhibitors;\n6. Have received steroid hormone within 7 days, chemotherapy, targeted therapy within 28 days, radiotherapy within 14 days, anti-cancer antibody therapies within 28 days\n7. Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the oral administration and absorption of the study drug\n8. Have received autologous stem cell transplant within 3 months before the first dose, or allogeneic stem cell transplant within 6 months before the first dose\n9. Presence of active graft-versus-host disease\n10. Have undergone a major surgery within 28 days\n11. Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection\n12. Have cardiac impairment as defined per protocol\n13. Have prior history of malignancies other than follicular lymphoma'}, 'identificationModule': {'nctId': 'NCT03934567', 'briefTitle': 'A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xynomic Pharmaceuticals, Inc.'}, 'officialTitle': 'An Open-label, Single-arm, Multi-center Phase 2 Study to Evaluate the Efficacy and Safety of Oral Histone Deacetylase (HDAC)-Inhibitor Abexinostat, as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma (FL)', 'orgStudyIdInfo': {'id': 'XYN-605'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abexinostat 80 mg bis in die (BID)', 'description': 'Experimental: Abexinostat 80 mg BID', 'interventionNames': ['Drug: Abexinostat']}], 'interventions': [{'name': 'Abexinostat', 'type': 'DRUG', 'description': 'Abexinostat tablets', 'armGroupLabels': ['Abexinostat 80 mg bis in die (BID)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'country': 'China', 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100029', 'city': 'Beijing', 'country': 'China', 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100191', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '130012', 'city': 'Changchun', 'country': 'China', 'facility': 'Jilin Cancer Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '610041', 'city': 'Chengdu', 'country': 'China', 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '116011', 'city': 'Dalian', 'country': 'China', 'facility': 'The First Affiliated Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'zip': '350001', 'city': 'Fuzhou', 'country': 'China', 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510030', 'city': 'Guangzhou', 'country': 'China', 'facility': 'Cancer Center of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510120', 'city': 'Guangzhou', 'country': 'China', 'facility': 'Sun Yai-Sen Memorial Hospital, Sun Yai-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510515', 'city': 'Guangzhou', 'country': 'China', 'facility': 'Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '570311', 'city': 'Hainan', 'country': 'China', 'facility': 'Hainan General Hospital', 'geoPoint': {'lat': 32.49432, 'lon': 120.45453}}, {'zip': '310009', 'city': 'Hangzhou', 'country': 'China', 'facility': 'The Second Affiliated Hospital Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310020', 'city': 'Hangzhou', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital, Zhejiang University School of Medical', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310022', 'city': 'Hangzhou', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '150081', 'city': 'Harbin', 'country': 'China', 'facility': 'The Affiliated Tumor Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '730000', 'city': 'Lanzhou', 'country': 'China', 'facility': 'The First Hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '276000', 'city': 'Linyi', 'country': 'China', 'facility': 'Linyi Cancer Hospital', 'geoPoint': {'lat': 35.06306, 'lon': 118.34278}}, {'zip': '226361', 'city': 'Nantong', 'country': 'China', 'facility': 'Nantong Tumor Hospital', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'zip': '200025', 'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai Sixth people's hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '050011', 'city': 'Shijiazhuang', 'country': 'China', 'facility': 'The Forth Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '300000', 'city': 'Tianjin', 'country': 'China', 'facility': "Tianjin People's Hospital", 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '300052', 'city': 'Tianjin', 'country': 'China', 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '221006', 'city': 'Xuzhou', 'country': 'China', 'facility': 'The Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'zip': '450008', 'city': 'Zhengzhou', 'country': 'China', 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '450052', 'city': 'Zhengzhou', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'overallOfficials': [{'name': 'Yuankai SHI, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xynomic Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}