Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-28 @ 6:09 PM
Study NCT ID:
NCT04865458
Status:
UNKNOWN
Last Update Posted:
2022-05-06
First Post:
2021-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2021-04-26', 'studyFirstSubmitQcDate': '2021-04-26', 'lastUpdatePostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose limited toxicities evaluated with NCI-CTC AE v5.0 after the first dose', 'timeFrame': 'Dosing started until the 28th day', 'description': 'Incidence of dose limited toxicities and associated dose of HEC89736'}, {'measure': 'Adverse events evaluated by NCI CTCAE 5.0', 'timeFrame': 'From the frst dose to within 30 days after the last dose', 'description': 'Incidence of adverse events and associated dose of HEC89736'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed or Refractory B-cell Hematologic Malignancies']}, 'descriptionModule': {'briefSummary': 'Evaluate the safety, pharmacokinetics and efficacy of HEC89736 in patients with Relapsed or Refractory B-cell Hematologic Malignancies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age is over 18 years old\n* Histologically or cytologically diagnosed patients with recurrent or refractory B-cell malignancies\n* ECOG performance status (PS) 0 \\~ 1\n* Expected survival of \\> or = 3 months\n\nExclusion Criteria:\n\n* The use of PI3Ks as the target of anti-tumor drugs progress (due to intolerance group)\n* Received any other anti-cancer treatment within 4 weeks\n* Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug use and absorption\n* Allergy, or known to have a history of allergy to the drug components'}, 'identificationModule': {'nctId': 'NCT04865458', 'briefTitle': 'A Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sunshine Lake Pharma Co., Ltd.'}, 'officialTitle': 'A Phase I Single Arm,Open-label,Multiple Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies', 'orgStudyIdInfo': {'id': 'HEC89736-P-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HEC89736 treatment', 'description': 'HEC89736 tablets,25 mg, 50 mg, 100 mg, 150 mg, 200 mg, QD, 28 days for each cycle', 'interventionNames': ['Drug: HEC89736']}], 'interventions': [{'name': 'HEC89736', 'type': 'DRUG', 'description': 'HEC89736 tablets QD every 28 days for each cycle', 'armGroupLabels': ['HEC89736 treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Li Jianyong, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}, {'name': 'Song Yuqing, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunshine Lake Pharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}