Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 2:41 AM
Study NCT ID:
NCT04827069
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Evaluate Clifutinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia(AML)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Arm 1:10 mg Arm 2:20 mg Arm 3:40 mg Arm 4:55 mg Arm 5:70 mg Arm 6: 100 mg'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-31', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD)', 'timeFrame': 'day 1-28', 'description': 'Safety and Tolerability assessed through adverse events to determine maximum tolerated dose'}], 'secondaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'On day 1,8,15,22,28', 'description': 'to assess the pharmacokinetic profile in patients with AML'}, {'measure': 'Time of maximum observed plasma concentration (Tmax)', 'timeFrame': 'On day 1,8,15,22,28', 'description': 'to assess the pharmacokinetic profile in patients with AML'}, {'measure': 'Area under the plasma concentration time curve', 'timeFrame': 'On day 1,8,15,22,28', 'description': 'to assess the pharmacokinetic profile in patients with AML'}, {'measure': 'Composite CR rate', 'timeFrame': 'up to 18 months', 'description': 'CR + CRi +CRMRD-'}, {'measure': 'Duration of response', 'timeFrame': 'up to 18 months', 'description': 'The time from receive CR / CRi/CRMRD-/PR to relapse'}, {'measure': 'Objective response rate', 'timeFrame': 'up to 18 months', 'description': 'CR + CRi +CRMRD- + PR'}, {'measure': 'Event Free Survival', 'timeFrame': 'up to 18 months', 'description': 'From the first time taking experimental drug to treatment failure or progression or relapse or death'}, {'measure': 'Overall Survival', 'timeFrame': 'up to 18 months', 'description': 'From the first time taking experimental drug to death'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of Clifutinib Besylate in Relapsed/refractory AML patients with FLT3-ITD mutation.', 'detailedDescription': 'It is a multi-center , open-label, single arm study conducted in 2 parts. Dose-escalation part: Subjects will receive oral Clifutinib Besylate once on C0D1.After 3 days,they will receive Clifutinib Besylate once daily repeatedly until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days.\n\nExpansion part:Expansion cohort might be set to further investigate the safety and efficacy of Clifutinib Besylate at or lower MTD dose recommended by dose-escalation part.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented acute myeloid leukemia according to World Health Organization（WHO） criteria(excluding acute promyelocytic leukemia), with FLT3-ITD gene mutation,refractory after common or enhanced chemotherapy or relapse.\n* ECOG performance status of 0-1.\n* Subjects must have adequate organ function and meeting all of the following laboratory review before enrollment：\n\n * Lood routine examination: WBC≤2000/mm3;\n * Liver function: Alanine aminotransferase (ALT) and Aspartate transaminase (AST) ≤2.5×upper limit of normal(ULN); serum bilirubin ≤ 1.5 × ULN;\n * Renal function: Serum creatinine ≤ 1.5×ULN, or the creatinine clearance (CrCl)≥ 60 mL / min calculated by the Cockcroft-Gault formula;\n * Electrolyte: serum potassium≥3.0mmol/L; serum calcium≥2.0 mmol/L;serum magnesium≥0.5 mmol/L;\n * Coagulation function:fibrinogen≥1.0g/L; activated partial thromboplastin time( APTT)≦ULN+10s; prothrombin time(PT)≤ULN+3s.\n\nExclusion Criteria:\n\n* Received FLT3 inhibitors within 4 weeks prior to the administration;\n* Received hematopoietic stem cell transplantation within2 months prior to the administration or received immunosuppressor beceause of GVHD;\n* Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks prior to administration;\n* Nitrosourea and mitomycin chemotherapy within 6 weeks prior to the administration;\n* Have taken live vaccines within 4 weeks prior to /or concurrent with the administration;\n* Have received a trial investigational product, or participated in other clinical trials within 4 weeks prior to administration;\n* Documented promyelocytic leukemia (t (15; 17) (q22; q11) and / or promyelocytic leukemia(PML)/retinoic acid receptor alpha (RARa) positivity found in the chromosome, variant acute promyelocytic leukemia;\n* With myeloid sarcoma or invasion of central nervous system;\n* NCI CTCAE 4.03 ≥ 2 grade of arrhythmia, or corrected QT interval(QTc )\\> 450 ms ; patients with a history of torsion or congenital QT prolonged syndrome; active infectious disease judged by the investigator.'}, 'identificationModule': {'nctId': 'NCT04827069', 'briefTitle': 'A Clinical Trial to Evaluate Clifutinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia(AML)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sunshine Lake Pharma Co., Ltd.'}, 'officialTitle': 'A Phase I, Multi-center, Open,Single Arm, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Clifutinib Besylate(HEC73543) in Relapsed or Refractory Acute Myeloid Leukemia (AML)', 'orgStudyIdInfo': {'id': 'PCD-DHEC73543-16-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Clifutinib Besylate:10 mg', 'interventionNames': ['Drug: Clifutinib Besylate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Clifutinib Besylate:20 mg', 'interventionNames': ['Drug: Clifutinib Besylate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': 'Clifutinib Besylate:40 mg', 'interventionNames': ['Drug: Clifutinib Besylate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4', 'description': 'Clifutinib Besylate:55 mg', 'interventionNames': ['Drug: Clifutinib Besylate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5', 'description': 'Clifutinib Besylate:70 mg', 'interventionNames': ['Drug: Clifutinib Besylate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 6', 'description': 'Clifutinib Besylate:100 mg', 'interventionNames': ['Drug: Clifutinib Besylate']}], 'interventions': [{'name': 'Clifutinib Besylate', 'type': 'DRUG', 'otherNames': ['HEC73543'], 'description': 'receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3', 'Arm 4', 'Arm 5', 'Arm 6']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanzhou', 'country': 'China', 'facility': 'the First Affiliated Hospital,College of Medicine,Zhejiang University', 'geoPoint': {'lat': 26.4965, 'lon': 99.437}}], 'overallOfficials': [{'name': 'Jie Jin, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunshine Lake Pharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}