[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100433238":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":44,"locations":50,"responsibleParty":69,"collaborators":32,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":32,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":32,"overallStatus":53,"whyStopped":32,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Chipscreen Biosciences, Ltd.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Chiauranib plus weekly paclitaxel","EXPERIMENTAL","Patients receive the combined treatment of chiauranib plus paclitaxel, 21 days for a cycle, 6 cycles at most,Chiauranib is given orally, 50mg once daily. Paclitaxel is given in intravenous infusion on Day 1, 8 and 15. After 6 cycles combined treatment, patients enter the single agent therapy of chiauranib.",[13,14],"Drug: chiauranib","Drug: Paclitaxel",{"label":16,"type":17,"description":18,"interventionNames":19},"placebo plus weekly paclitaxel","PLACEBO_COMPARATOR","Patients receive the combined treatment of placebo plus paclitaxel, 21 days for a cycle, 6 cycles at most,placebo is given orally, 50mg once daily. Paclitaxel is given in intravenous infusion on Day 1, 8 and 15. After 6 cycles combined treatment, patients enter the single agent therapy of placebo.",[20,14],"Drug: Placebo",[22,29,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","chiauranib","50mg orally once daily",[9],[28],"CS2164",{"type":23,"name":30,"description":25,"armGroupLabels":31,"otherNames":32},"Placebo",[16],null,{"type":23,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Paclitaxel","at the first cycle, 60mg\u002Fm2, i.v infusion on day 1, 8 and 15 ; at the begining of the second cycle, after a comprehensive assessment , investigators decide whether to increase the dosage to 80mg\u002Fm2, i.v infusion on day 1, 8 and 15 ;",[9,16],[38],"Anzatax",[40],{"name":41,"affiliation":42,"role":43},"Xiaohua Wu","Fudan university Shanghai cancer centre","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":32,"email":49},"Yu Chen","CONTACT","8610-56102349","chenyu@chipscreen.com",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":55,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","China","200032","CN",{"type":59,"coordinates":60},"Point",[61,62],121.45806,31.22222,{"lat":62,"lon":61},[65,68],{"name":66,"role":47,"phone":67,"phoneExt":32,"email":32},"Xiaohua Wu, MD","13601772486",{"name":66,"role":47,"phone":32,"phoneExt":32,"email":32},{"type":70,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100433238","phase-3-chiauranib-plus-weekly-paclitaxel-in-patients-with-platinum-refractory-or-platinum-resistant-recurrent-ovarian-cancer-100433238",false,"NCT04921527","Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer","A Multi-center, Double-blind, Randomized Phase III Clinical Trial of Chiauranib Plus Weekly Paclitaxel in Patients with Platinum-refractory or Platinum-resistant Recurrent Ovarian Cancer","CHIPRO","Inclusion Criteria:\n\n* Willingness to sign a written informed consent document .\n* Female, age ≥18 yrs and ≤70 yrs.\n* Histological or cytological confirmation of epithelial ovarian cancer, carcinoma tube, or primary peritoneal carcinoma.\n* Patients with platinum refractory or platinum resistant ovarian cancer:\n\n  * Platinum refractory: progression during the first platinum-based treatment or within 4 weeks after the first platinum-based primary therapy;\n  * Platinum resistant: progression during the platinum-based treatment except for platinum refractory, or within 6 months after the last receipt of platinum-based treatment (patients have received platinum containing chemotherapy at least 4 weeks);\n  * Radiological progression during the last treatment administered;\n  * no more than 1 prior treatment regimens for recurrent disease.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* At least 1 lesion can be accurately measured, as defined by RECIST1.1.\n* Laboratory criteria are as follows:\n\n  * Complete blood count: hemoglobin (Hb) ≥90g\u002FL ; absolute neutrophil count (ANC) ≥1.5×109\u002FL ; platelets ≥90×109\u002FL;\n  * Biochemistry test: serum creatinine(cr) \\\u003C1.5×ULN; total bilirubin\\\u003C1.5×ULN; alanine aminotransferase(ALT) ,aspartate aminotransferase(AST)≤2.5×ULN; (ALT,AST≦5×ULN if liver involved) ;\n  * Coagulation test: International Normalized Ratio (INR) \\\u003C 1.5, activeated partial thromboplasting time (APTT) \\\u003C1.5×ULN\n* Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Patients received vascular endothelial growth factor(VEGF)\u002Fvascular endothelial growth factor receptor(VEGFR) inhibitor, like Apatinib, Anlotinib, Fruquintinib, Bevacizumab, etc., or Aurora kinase inhibitors.\n* Patients received weekly paclitaxel therapy.\n* Has known allegies to Chiauranib, paclitaxel or any of the excipients.\n* Biological therapy, immunotherapy, hormonal therapy within 28 days prior to the first dose of study drug.\n* prior major surgery or trauma within 14 days prior to first dose of study drug and\u002For presence of any non-healing wound, fracture, or ulcer.\n* Treatment with an investigational agent\u002Finstrument within 28 days prior to first dose of study drug.\n* Any ongoing toxicity from prior anti-cancer therapy that is \\>Grade 1.\n* Patients with prior invasive malignancies in the past five years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.\n* History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.\n* clinically significant central\u002Fperipheral nervous system disease.\n* Have uncontrolled or significant cardiovascular disease, including:\n\n  * Congestive heart failure, unstable angina pectoris, myocardial infarction within 6 months prior to study entry; arrhythmia, or Left Ventricular Ejection Fraction (LVEF) \\\u003C 50% requiring treatment with agents during screening stage.\n  * primary cardiomyopathy(dilated cardiomyopathy, hypertrophic cardiomyocyte, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, et,al)\n  * History of significant QT interval prolongation, or Corrected QT Interval (QTc) \\> 470 ms prior to study entry\n  * Symptomatic coronary heart disease requiring treatment with agents\n  * History of hypertension treated by≥2 agents, or the Blood pressure (Bp) ≥140\u002F90 mmHg prior to study entry.\n  * Other condition investigator considered inappropriate\n* Significant intravenous or arterial thrombosis, such as cerebrovascular accident, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.\n* History of active bleeding within the past 2 months, patients with bleeding potential during the screening period, or receiving anticoagulation therapy.\n* CT or MRI of the chest during the screening period shows interstitial lung disease or pulmonary fibrosis or lung inflammation that requires treatment, or within 6 months before the first dose, history of pneumonia requiring oral or intravenous steroid treatment, history of immune-associated pneumonia after treatment of PD1\u002FPDL1 inhibitor.\n* Have clinical significant gastrointestinal abnormality that would impair the ingestion, transportation or absorption of oral agents, history of gastrointestinal perforation or abdominal fistula, peptic ulcer disease within 6 months prior to first dose of study drug or GI obstruction within the past 3 months.\n* Pleural fluid, ascites or pericardial effusion with significant symptoms or required treatment of puncture or drainage during the screening period, or history of drainage for therapy within 1 months prior to first dose of study drug.\n* Screening for HIV antibody positive.\n* Screening test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with virus replication, hepatitis C antibody (HCV-Ab) positive with virus replication.\n* Active infection requiring oral or intravenous systemic antimicrobial therapy during the screening period.\n* Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study.\n* History of organ transplantation or allo-HSCT.\n* Any mental or cognitive disorder, that would impair the ability to understand the informed consent document, or the compliance of study.\n* Candidates with drug and alcohol abuse.\n* Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study.Pregnant or breastfeeding women.\n* Any other condition which is inappropriate for the study in the opinion of the investigators.","FEMALE","18 Years","70 Years",{"count":83,"type":84},454,"ESTIMATED","INTERVENTIONAL",[87],"PHASE3","This randomized, double-blind, 2-arm study will evaluate the efficacy and safety of Chiauranib plus weekly paclitaxel versus placebo plus weekly paclitaxel in patients with Platinum-refractory or Platinum-resistant Recurrent ovarian cancer.",[90,91,92,34],"Ovarian Cancer","Relapsed or Refractory","Chiauranib","2024-10-17",{"date":95,"type":96},"2024-10-18","ACTUAL",{"date":98,"type":96},"2021-12-20",{"date":100,"type":84},"2025-07-31",{"name":5,"class":6},1]