Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT03494634
Status:
UNKNOWN
Last Update Posted:
2018-04-11
First Post:
2018-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chidamide for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009374', 'term': 'Neoplasms, Experimental'}], 'ancestors': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C547816', 'term': 'N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-04', 'studyFirstSubmitDate': '2018-04-04', 'studyFirstSubmitQcDate': '2018-04-04', 'lastUpdatePostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'objective response rate（ORR）', 'timeFrame': 'up to 2 years', 'description': 'the total proportion of patients with complete response（CR）and partial response（PR）'}], 'secondaryOutcomes': [{'measure': 'Disease Control Rate （DCR）', 'timeFrame': 'up to 2 years', 'description': 'the total proportion of patients with complete response（CR）, partial response（PR）and Stable Disease（SD）'}, {'measure': 'Duration of Response （DOR）', 'timeFrame': 'up to 2 years', 'description': 'Time from first documented complete response (CR) or partial response (PR) until time of progression.'}, {'measure': 'progression-free survival（PFS）', 'timeFrame': '2 years', 'description': 'Time from treatment until disease progression or death'}, {'measure': 'overall survival（OS）', 'timeFrame': '2 years', 'description': 'Time from treatment until death from any cause'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Experimental Tumor']}, 'descriptionModule': {'briefSummary': 'Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr virus (EBV)-associated Solid Tumors', 'detailedDescription': 'Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide as a single-agent treatment in patients with recurrent and metastatic Epstein-Barr virus (EBV)-associated solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed as recurrent and metastatic Epstein-Barr virus (EBV)-associated solid tumors, including nasopharyngeal carcinoma and other solid tumors (Lymphoma excluded). Patients must have failed at least one systemic treatment and been refractory to platinum-containing regimens;\n2. At least one measurable lesion according to criteria RECIST v1.1;\n3. Age 18-70 years, male or female;\n4. ECOG performance status 0-2;\n5. Life expectancy no less than 3 months;\n6. Adequate hepatic, renal and bone marrow function;\n7. History of brain metastasis is eligible, but maintenance of hormone is not required;\n8. Contraception during and 4 weeks after the study for patients at child bearing age;\n9. Patients have signed the Informed Consent Form.\n\nExclusion Criteria:\n\n1. Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures;\n2. QTc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;\n3. pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;\n4. Patients have undergone organ transplantation;\n5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment;\n6. Patients with active hemorrhage;\n7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction;\n8. Patients with active HBV or HCV infection;\n9. continuous fever within 14 days prior to enrollment;\n10. Had major organ surgery within 6 weeks prior to enrollment;\n11. Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum);\n12. Patients with mental disorders or those do not have the ability to consent;\n13. Patients with drug abuse, long term alcoholism that may impact the results of the trial;\n14. Patients who received treatment of HDAC inhibitors;\n15. Non-appropriate patients for the trial according to the judgment of the investigators.'}, 'identificationModule': {'nctId': 'NCT03494634', 'briefTitle': 'Chidamide for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors', 'orgStudyIdInfo': {'id': 'CSIIT-Q08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chidamide', 'interventionNames': ['Drug: Chidamide']}], 'interventions': [{'name': 'Chidamide', 'type': 'DRUG', 'description': 'Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.', 'armGroupLabels': ['Chidamide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Cancer Center of Sun Yat-Sen University (CCSU)', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Li Zhang, MD', 'role': 'CONTACT', 'email': 'zhangli6@mail.sysu.edu.cn', 'phone': '86-20-87343458'}, {'name': 'Wenfeng Fang, MD', 'role': 'CONTACT', 'email': 'Fangwf@sysucc.org.cn'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director', 'investigatorFullName': 'Li Zhang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}