[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508858":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":30,"responsibleParty":50,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":11,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":11,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Asan Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"rivoceranib plus paclitaxel","EXPERIMENTAL",null,[13],"Drug: Rivoceranib Mesylate, Paclitaxel",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Rivoceranib Mesylate, Paclitaxel","Paclitaxel will be administered at 80mg\u002Fm2\u002Fday every four weeks at Day 1, Day 8 and Day 15 per cycle. One cycle consists of 4 weeks (28 days).\n\nRivoceranib 400 mg orally once a day.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Ryu Min-Hee, MD, PhD","CONTACT","82-2-3010-5935","miniryu@amc.seoul.kr",{"name":27,"role":23,"phone":28,"phoneExt":11,"email":29},"kim Hyung-Don, MD, PhD","82-2-3010-0236","kimhdmd@amc.seoul.kr",[31],{"facility":32,"status":33,"city":34,"state":34,"zip":35,"country":36,"countryCode":11,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Asan Medical Center, University of Ulsan College of Medicine","RECRUITING","Seoul","138-736","South Korea",{"type":38,"coordinates":39},"Point",[40,41],126.9784,37.566,{"lat":41,"lon":40},[44,47],{"name":45,"role":23,"phone":46,"phoneExt":11,"email":25},"Min-Hee Kang, MD, PhD","+82-2-3010-5935",{"name":48,"role":23,"phone":49,"phoneExt":11,"email":29},"Hyung-Don Kim, MD, PhD","+82-2-3010-0236",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Min-Hee Ryu","Professor","100508858","phase-2-rivoceranib-plus-paclitaxel-in-patients-with-gastrointestinal-stromal-tumor-100508858",false,"NCT05905887","Rivoceranib Plus Paclitaxel in Patients With Gastrointestinal Stromal Tumor","A Phase 2 Study of Paclitaxel Plus Rivoceranib in Patients With GIST With a High P-glycoprotein Expression After Failure With at Least Imatinib, Sunitinib and Regorafenib","Inclusion Criteria:\n\n* Age 20 years or older, at the time of acquisition of informed consent\n* Histologically confirmed metastatic and\u002For advanced GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene\n* P-glycoprotin IHC score \\> 3 (Tumor tissue with disease progression after regorafenib treatment)\n* Failed (progressed and\u002For intolerable) after prior treatments for GIST, including at least imatinib and sunitinib, regorafenib.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 \\~ 2\n* Resolution of all toxic effects of prior treatments to grade 0 or 1 by NCI-CTCAE version 5.0\n* At least one measurable lesion as defined by RECIST version 1.1.\n* Adequate bone marrow, hepatic, renal, and other organ functions Neutrophil \\>1,500\u002Fmm3 Platelet \\> 100,000\u002Fmm3 Hemoglobin \\>8.0 g\u002FdL Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) AST\u002FALT \\\u003C 2.5 x ULN Creatinine \\\u003C1.5 x ULN\n* Life expectancy \\> 12 weeks\n* Washout period of previous TKIs or chemotherapy for more than 4 times the half life ((Imitinib and regorafenib need 1 week and sunitinib need 2 weeks.)\n* Provision of a signed written informed consent\n\nExclusion Criteria:\n\n* Women of child-bearing potential who are pregnant or breast feeding\n* Women or men who are not willing to use effective contraception entering the study period or until at least 3 months after the last study drug administration.\n* If any of the following applies within ≤ 6 months prior to starting study enrollment : Myocardial Infarction, severe instable angina, coronary\u002Fperipheral bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, treatment required severe arrhythmia.\n* Uncontrolled infection\n* Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible)\n* Uncontrolled gastrointestinal toxicities with toxicity greater than NCI CTCAE grade 2\n* Acute, or chronic medical or psychiatric condition or laboratory abnormality such as active uncontrolled infection that difficult to study participation in the judgment of the investigator\n* The patient experienced any bleeding episode considered life-threatening, or any grade 3 or 4 bleedig event. (required transfusion or endoscopic or surgical intervention)\n* Currently clinically significant (within 7 days prior to screening) treatment of anticoagulants or other thrombolytic agents. A maximum dose of 325 mg\u002Fday of aspirin is allowed\n* History of uncontrolled hypertension (blood pressure ≥140\u002F90 mmHg and change in antihypertensive medication within 7 days prior to screening) that is not well managed by medication and the risk of which may be precipitated by a VEGF inhibitor therapy.\n* History of clinically serious opearation, bone fracture or non-healing wounds within the last 3 weeks prior to screening\n* History of other significant cardiovascular diseases or vascular diseases, within the last 6 months prior to screening (e.g., hypertensive crisis, and hypertensive encephalopathy or transient ischemic attack or significant peripheral vascular diseases\\] that, in the investigator's opinion, may pose a risk to the patient on VEGFR inhibitor therapy.\n* History of clinically significant glomerulonephritis, biopsy-proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies\n* Known diagnosis of HIV infection (HIV testing is not mandatory).\n* History of another primary malignancy that is currently clinically significant or currently requires active intervention.\n* Patients with clinically suspected brain metastasis symptom, brain metastases as assessed by radiologic imaging\n* Alcohol or substance abuse disorder.\n* Known hypersensitivity to rivoceranib or any component of its formulation or history of severe hypersensitivity to including Cremophor R EL(polyoxyethylated castor oil) drug\n* Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19\n* Active bacterial infections","ALL","20 Years",{"count":64,"type":65},48,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of rivoceranib and paclitaxel combination therapy in patients with P-glycoprotein overexpressing GIST who failed standard treatment with imatinib, sunitinib, and regorafenib.",[71],"Gastrointestinal Stromal Tumors","2026-04-02",{"date":74,"type":75},"2026-04-07","ACTUAL",{"date":77,"type":75},"2023-09-06",{"date":79,"type":65},"2027-12-31",{"name":5,"class":6},1]