[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550962":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":51,"collaborators":53,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":20,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":20,"enrollmentInfo":84,"targetDuration":20,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Shenzhen TargetRx Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: TGRX-678","EXPERIMENTAL","All patients with CML-AP to be treated with TGRX-678. Patients with T315I mutation or without T315I mutation will be assigned into separate cohorts for evaluation",[13],"Drug: TGRX-678",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","TGRX-678","All patients will be given TGRX-678 240 mg once daily. TGRX-678 is to be taken orally",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Qian Jiang, MD","Peking University People's Hospital","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Yingkun Lu","CONTACT","18602219981","yingkun.lv@tjrbiosciences.com",[33],{"facility":24,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":41,"coordinates":42},"Point",[43,44],116.39723,39.9075,{"lat":44,"lon":43},[47,50],{"name":23,"role":29,"phone":48,"phoneExt":20,"email":49},"010-88326666","Jiangqian@medmail.com",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[54,56,59,61,63,65,67,69,71,73],{"name":24,"class":55},"OTHER",{"name":57,"class":58},"Henan Cancer Hospital","OTHER_GOV",{"name":60,"class":55},"Nanfang Hospital, Southern Medical University",{"name":62,"class":55},"The First Affiliated Hospital of Soochow University",{"name":64,"class":55},"Chinese Academy of Medical Sciences",{"name":66,"class":55},"First Affiliated Hospital of Zhejiang University",{"name":68,"class":55},"Shenzhen Second People's Hospital",{"name":70,"class":55},"Ruijin Hospital",{"name":72,"class":55},"Shengjing Hospital",{"name":74,"class":55},"Huazhong University of Science and Technology","100550962","phase-2-tgrx-678-chinese-phase-ii-in-chronic-myelogenous-leukemia-cml-patients-100550962",false,"NCT06453902","TGRX-678 Chinese Phase II in Chronic Myelogenous Leukemia (CML) Patients","A Single-arm, Open-label, Multi-center Phase II Study Evaluating Efficacy and Safety of TGRX-678 in CML-AP Patients Relapsed or Refractory From 3rd-generation TKI Treatment","Inclusion Criteria:\n\n* Willing to consent\n* 18 years of age or above at time of screening; both sexes eligible\n* Relapsed or refactory from 3rd-generation Tyrosine kinase inhibitor (TKI) treatment\n* For patients without T315I mutation, the patients must received 1st, 2nd and 3rd generation TKI\n* For patients with T315I mutation, the patients much received Olverembatinib or Ponatinib treatment\n* Diagnosis of CML-AP by bone marrow morphological test, molecular biology test or cytogenetic tests\n* ECOG score \\\u003C\u002F=2\n* Minimum life expectancy of at least 3 months\n* Adequate hematological indicators\n* Adequate kidney function\n* Adequate liver function\n* Adequate coagulation function\n* Adequate pancreatic function\n* Adequate QTc interval as confirmed by electrocardiogram (ECG) test\n* Negative pregnancy result at screening for female patients of child-bearing potential\n* Willing to take contraceptive measure during the study (For male and female patients of child-bearing potential)\n\nExclusion Criteria:\n\n* Reception of TKI treatment or presence of unrecovered TKI treatment related non-hematological adverse events within 7 days of first dose\n* Reception of other anti-tumor treatments\n* In need for immune suppressive treatment\n* Usage of drugs associated with Torsades de Pointes within 1 months before screening\n* Presence of other medical conditions that require using treatment that may have drug-drug interaction with the investigational drug\n* History of hemapoietic stem cell transplant\n* Presence of active central nervous system conditions\n* CML-AP patients who already reached major hematological response\n* CML-AP patients who used to progress to Blast Phase (BP)\n* Presence or having uncontrolled condition for cardiovascular diseases\n* History of any heart or cardiovascular conditions (except for patients with hypertension which is controlled by anti-hypertensive drugs, and blood pressure is controlled at no higher than 160\u002F100 mmHg for 1 months before screening)\n* Usage of any Traditional Chinese Medicine indicated for anti-tumor purpose 2 weeks before first dose\n* Severe hemorrhagic disease unrelated to CML\n* History of severe cardiovascular condition during past TKI treatment for CML\n* History of pancreatic inflammation or alcohol abuse within 3 years before first dose\n* Uncontrolled Hypertriglyceridemia\n* Presence of malabsorption or other conditions that may affect drug absorption\n* Diagnosis of other primary malignant tumor within 5 years\n* Reception of major surgery 14 days before first dose\n* Presence of continuous or active infection (including HIV, hepatitis B, hepatitis C)\n* Presence of other conditions that the investigators or medical monitor deem unfit for the study","ALL","18 Years",{"count":85,"type":86},40,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","A Phase II study evaluating the safety and efficacy of TGRX-678 in Chronic Myelogenous Leukemia (CML) patients in Accelerated phase (AP) and are relapsed or refractory from third-generation Tyrosine Kinase Inhibitor (TKI) treatment",[92,93],"Chronic Myeloid Leukemia","Accelerated Phase CML","2025-02-19",{"date":96,"type":97},"2025-02-21","ACTUAL",{"date":99,"type":97},"2024-07-15",{"date":101,"type":86},"2028-04-30",{"name":5,"class":6},1]