[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473458":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":29,"responsibleParty":44,"collaborators":19,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":19,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":19,"studyType":59,"phases":60,"briefSummary":63,"conditions":64,"keywords":19,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SKLB1028 Dose Escalation","EXPERIMENTAL","Part1:Patients will receive a standard combination of chemotherapy drugs during remission induction therapy that includes cytarabine, daunorubicin, and the experimental drug SKLB1028.SKLB1028 capsules beginning at 100 mg bid.\n\nPart2: Once the appropriate therapeutic schedule has been established in Part 1, up to 20 subjects will be enrolled into an expansion cohort.",[13],"Drug: SKLB1028 Dose Escalation",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Drug :SKLB1028 ;Drug: Cytarabine ;Drug: Daunorubicin",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Liu Ting, Chief doctor","CONTACT","+8618980601240","liuting@scu.edu.cn",{"name":27,"role":23,"phone":19,"phoneExt":19,"email":28},"Wang Jianxiang, Chief doctor","wangjx@ihcams.ac.cn",[30],{"facility":31,"status":32,"city":33,"state":19,"zip":19,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"West China Hospital of Sichuan University","RECRUITING","Chengdu","China","CN",{"type":37,"coordinates":38},"Point",[39,40],104.06667,30.66667,{"lat":40,"lon":39},[43],{"name":22,"role":23,"phone":19,"phoneExt":19,"email":19},{"type":45,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100473458","phase-1-sklb1028-daunorubicin-and-cytarabine-in-treating-patients-with-newly-diagnosed-acute-myeloid-leukemia-aml-100473458",false,"NCT05445154","SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)","A Single-Arm, Multicenter, Open-Label, Dose- Escalating and Expanding,Phase I\u002FII Study of SKLB1028 Combined With \"7+3\" Standard Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n1. Subject has a diagnosis of previously-untreated de novo acute myeloid leukemia (AML) \\> 20% blasts in the bone marrow according to WHO classification (2016) documented prior to enrollment.;\n2. Age ≥ 18 and \\\u003C 60 years;\n3. Subjects who are positive for FLT3 mutations by central laboratory;\n4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n5. Subject must meet the following criteria as indicated on the clinical laboratory tests;\n\n   1. Serum aspartate aminotransf\n   2. Total serum bilirubin ≤ 2.5 x institutional ULN\n   3. Serum creatinine ≤ 3 x institutional ULN or an estimated glomerular filtration rate (eGFR) of \\> 30 ml\u002Fmin\n6. Subject is suitable for oral administration of study drug.\n\nExclusion Criteria:\n\n1. Confirmed diagnosis of acute promyelocytic leukemia (M3 \u002FAPL), or BCR-ABL positive leukemia (ie, blast crisis of chronic myelogenous leukemia);\n2. Diagnosis of active malignancy other than AML;\n3. AML secondary to radiotherapy or chemotherapy for other tumors;\n4. AML with central nervous system involvement;\n5. Refractory hypokalemia or hypomagnesemia that is not easily corrected by symptomatic treatment and that occurs repeatedly in the past;\n6. Current clinically significant graft-ve\n7. Previous history of other malignancies.\n8. Patients with clinically significant coagulation abnormalities, such as disseminated intravascular coagulation (DIC), hemophilia A, hemophilia B, and von Willebrand disease;\n9. Major surgery of major organs has been performed before entering the study (for the definition of major surgery, refer to Grade 3 and 4 surgery specified in Management Measures for Clinical Application of Medical Technology, or the patient has not yet fully recovered from\n10. Subject has received prior therapy for AML with the following exceptions: a. emergency leukapheresis; b. emergency treatment with hydroxyurea ;c. growth factor or cytokine support; d. steroid for anaphylaxis or transfusion reaction;","ALL","18 Years","59 Years",{"count":57,"type":58},58,"ESTIMATED","INTERVENTIONAL",[61,62],"PHASE1","PHASE2","The purpose of this study is to describe the dose limiting toxicities (DLT) of SKLB1028 when combined with cytarabine\u002F daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of SKLB1028 will also be evaluated. This study will also characterize the pharmacokinetics (PK) of SKLB1028 when given in combination with cytarabine\u002Fdaunorubicin remission induction and high-dose cytarabine (HiDAC) consolidation therapy in newly diagnosed acute myeloid leukemia .",[65],"Newly Diagnosed Acute Myeloid Leukemia (AML)","2022-06-30",{"date":68,"type":69},"2022-07-06","ACTUAL",{"date":71,"type":69},"2021-08-31",{"date":73,"type":58},"2026-12-31",{"name":5,"class":6},1]