[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100369678":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":55,"collaborators":57,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":53,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":53,"enrollmentInfo":74,"targetDuration":53,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":53,"overallStatus":37,"whyStopped":53,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Beijing Konruns Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (CX1003)","EXPERIMENTAL","Treatment will comprise 2 periods: a 4-day single dose period, followed by a period of daily-dose in continuous 28-day treatment cycle (the 1st cycle) or 21-day treatment cycles (the 2nd cycle and beyond).",[13],"Drug: CX1003",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","CX1003","Oral dose A 4-day single dose period, followed by a period of daily-dose in continuous 28-day treatment cycle (the 1st cycle) or 21-day treatment cycles (the 2nd cycle and beyond) Dosage range: 25 mg, 50mg, 75mg, 100mg,125mg,150mg,175mg",[9],[21],"kanitinib",[23],{"name":24,"affiliation":25,"role":26},"Yuankai Shi, Doctor","Cancer Institute and Hospital, Chinese Academy of Medical Sciences","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Junyu Wu, Ph.D","CONTACT","0086-10-53056686","2063","wujy@konruns.cn",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"National Cancer Center\u002FCancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College","RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":51,"role":30,"phone":52,"phoneExt":53,"email":54},"Yuankai Shi, Dr","008610-87788507",null,"syuankai@cicams.ac.cn",{"type":56,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR",[58,61,63],{"name":59,"class":60},"Chinese Academy of Medical Sciences","OTHER",{"name":62,"class":60},"West China Hospital",{"name":64,"class":60},"Beijing Tongren Hospital","100369678","phase-1-a-phase-1-study-of-cx1003-kanitinib-in-patients-with-advanced-solid-tumors-100369678",false,"NCT04093466","A Phase 1 Study of CX1003 (Kanitinib) in Patients with Advanced Solid Tumors","A Phase 1, Multicenter, Open-label, Dose Escalation\u002Fexpansion Study Evaluating the Safety, Pharmacokinetics and Preliminary Efficacy of CX1003 (Kanitinib) in the Patients with Relapsed Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed recurrent or metastatic solid tumors;\n* At least one measurable lesion (spiral CT scan long diameter ≥10 mm or enlarged lymph node short diameter ≥15 mm by RECIST 1.1);\n* Documented disease progression after, or refractory to, or intolerant of prior standard or established therapy known to provide clinical benefit for their condition; or documented disease progression within 24 weeks after prior adjuvant\u002Fneoadjuvant therapy;\n* ECOG PS ≤1;\n* Expected overall survival≥12 weeks;\n\nExclusion Criteria:\n\n* Untreated brain metastases or symptoms of brain metastases cannot be controlled more than 4 weeks;\n* Other kinds of malignancies \\[excluding stage IB or lower grade cervical cancer，noninvasive basal cell or squamous cell cancer, breast cancer with complete remission (CR) \\> 10 years ,melanoma with CR \\> 10 years or other malignant tumors with CR \\> 5 years\\];\n* Hematologic, renal, and hepatic function abnormities as defined below:\n\nAbsolute neutrophil count (ANC) \\\u003C1.5×109 \u002FL or platelet \\\u003C100×109 \u002FL or hemoglobin \\\u003C9 g\u002FdL; Total bilirubin \\> 1.5×the upper limit of normal range(ULN) without liver metastases; total bilirubin \\> 3×ULN with liver metastases; AST, ALT, ALP \\>1.5×ULN without liver metastases ; AST, ALT, ALP \\>5×ULN with liver metastases; Primary hepatocellular carcinoma; Hepatic cirrhosis with Child-Pugh B or C; Serum creatinine \\>1.5×ULN; History of previous nephrotic syndrome; INR or aPPT \\>1.5×ULN; Presence of hemorrhage (hemoptysis) , thrombosis，or currently receiving treatment with warfarin, aspirin, low molecular weight heparin (LMWH), or any other anti-platelet drugs (Aspirin ≤100 mg\u002Fd for prophylaxis are allowed); •Any of the following gastrointestinal disease: Unable to swallow oral drugs; Need intravenous nutrition; History of a gastric resection; History of treatment for active peptic ulcer disease within 6 months; Clinically significant gastrointestinal bleeding within 3 months; Persistent grade 2 or higher chronic diarrhea despite optimal medical management;\n\n•Any of the following cardiovascular and cerebrovascular disease: Myocardial infarction , severe cardiac arrhythmias, unstable angina, coronary artery disease, congestive heart failure, cerebrovascular accident or TIA within 12 months ; Deep vein thrombosis or pulmonary embolism within 6 months; QTcF \\>470 msec; Uncontrolled hypertension despite optimal medical management;\n\n* Presence of unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 grade 0 or 1 with the exception of alopecia;\n* Involved in other clinical trials within 30 days of enrollment;\n* Major surgical procedure, open biopsy, or significant traumatic injury within 30 days of enrollment;\n* History of organ allograft ;\n* Need glucocorticoids or other immunosuppressive agents for immunosuppression (excluding local or inhaled glucocorticoids);\n* Uncontrolled ongoing or active infection;\n* Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy;\n* Pregnant or lactating women or those who do not take contraceptives, including men;\n* Suffering from mental and neurological diseases;\n* Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings;\n* Inability to comply with protocol required procedures.","ALL","18 Years",{"count":75,"type":76},126,"ESTIMATED","INTERVENTIONAL",[79],"PHASE1","CX1003 is a novel multi-target tyrosine kinase inhibitor that is designed to primarily inhibit vascular endothelial growth factor receptor 2 (VEGFR2) and hepatocyte growth factor receptor (HGFR\u002FMET). This study aimed to evaluate the safety, pharmacokinetics, and antitumor activity of CX1003 in patients with refractory advanced or metastatic solid tumors.",[82],"Advanced Solid Tumor","2024-10-15",{"date":85,"type":86},"2024-10-17","ACTUAL",{"date":88,"type":86},"2020-04-27",{"date":90,"type":76},"2025-12",{"name":5,"class":6},1]