Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT03510767
Status:
UNKNOWN
Last Update Posted:
2023-04-14
First Post:
2018-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of TQ-B3525 on Tolerance and Pharmacokinetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730996', 'term': 'TQ-B3525'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2018-04-18', 'studyFirstSubmitQcDate': '2018-04-26', 'lastUpdatePostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-Limiting Toxicities (DLT)', 'timeFrame': 'Baseline up to 28 days', 'description': 'DLT: An adverse event occurring after initiation of TQ-B3525 that met any following criteria:\n\n1. \\>=Grade 3 of non-hematology toxicity\n2. Grade 4 hematology toxicity'}, {'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': 'Baseline up to 28 days', 'description': 'MTD was defined as the highest dose level studied for which the incidence of first cycle DLT was \\< 33%.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed or Refractory Lymphoma or Advanced Cancer']}, 'descriptionModule': {'briefSummary': 'To study the pharmacokinetic characteristics of TQ-B3525 in the human body, recommend a reasonable regimen for subsequent research.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Relapsed or refractory lymphoma or advanced solid tumor that diagnosed Pathologically or cytologically diagnosed\n* ECOG PS≤1\n* Adequate blood cell counts, kidney function and liver function\n* Patients should participate in the study voluntarily and sign informed consent\n\nExclusion Criteria:\n\n* Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history\n* Hypertension (systolic BP ≥150 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication\n* Hepatitis B virus patients with active replication (DNA\\> 500 cps / mL), hepatitis C'}, 'identificationModule': {'nctId': 'NCT03510767', 'briefTitle': 'A Study of TQ-B3525 on Tolerance and Pharmacokinetics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Phase I Study of TQ-B3525 on Tolerance and Pharmacokinetics', 'orgStudyIdInfo': {'id': 'TQ-B3525-I-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQ-B3525', 'interventionNames': ['Drug: TQ-B3525']}], 'interventions': [{'name': 'TQ-B3525', 'type': 'DRUG', 'description': 'TQ-B3525 p.o. qd', 'armGroupLabels': ['TQ-B3525']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300121', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huaqing Wang, doctor', 'role': 'CONTACT', 'email': 'huaqingw@163.com', 'phone': '+86-022-022-2757483'}], 'facility': "People's Hospital of Tianjin", 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Huaqing Wang, doctor', 'role': 'CONTACT', 'email': 'huaqingw@163.com', 'phone': '+86-022-022-2757483'}], 'overallOfficials': [{'name': 'Huaqing Wang, doctor', 'role': 'STUDY_CHAIR', 'affiliation': "People's Hospital of Tianjin Tianjin,China,300121"}, {'name': 'Wenqi Jiang, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Sun Yat-sen University Cancer Center,Guangzhou,Guangdong,China, 510060'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}