KCT0008554招募中Unknown
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.
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Age 20 years or older, at the time of acquisition of informed consent
- •Histologically confirmed metastatic and/or advanced GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRa gene
- •P-glycoprotin IHC score > 3 (Tumor tissue with disease progression after regorafenib treatment)
- •Failed (progressed and/or intolerable) after prior treatments for GIST, including at least imatinib and sunitinib, regorafenib.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 ~ 2
- •Resolution of all toxic effects of prior treatments to grade 0 or 1 by NCI-CTCAE version 5.0
- •At least one measurable lesion as defined by RECIST version 1.1.
- •Adequate bone marrow, hepatic, renal, and other organ functions Neutrophil >1,500/mm3 Platelet > 100,000/mm3 Hemoglobin >8.0 g/dL Total bilirubin < 1.5 x upper limit of normal (ULN) AST/ALT < 2.5 x ULN Creatinine <1.5 x ULN
- •Life expectancy > 12 weeks
- •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.)
- •Provision of a signed written informed consent
排除标准
- •Women of child-bearing potential who are pregnant or breast feeding
- •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.
- •If any of the following applies within = 6 months prior to starting study enrollment : Myocardial Infarction, severe instable angina, coronary/peripheral bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, treatment required severe arrhythmia.
- •Uncontrolled infection
- •Acute and chronic liver disease and all chronic liver impairment.(But Patients with stable chronic hepatitis B are eligible)
- •Uncontrolled gastrointestinal toxicities with toxicity greater than NCI CTCAE grade 2
- •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
- •The patient experienced any bleeding episode considered life-threatening, or any grade 3 or 4 bleedig event. (required transfusion or endoscopic or surgical intervention)
- •Currently clinically significant (within 7 days prior to screening) treatment of anticoagulants or other thrombolytic agents. A maximum dose of 325 mg/day of aspirin is allowed
- •History of uncontrolled hypertension (blood pressure =140/90 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.
- •History of clinically serious opearation, bone fracture or non-healing wounds within the last 3 weeks prior to screening
- •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.
- •History of clinically significant glomerulonephritis, biopsy-proven tubulointerstitial nephritis, crystal nephropathy, or other renal insufficiencies
- •Known diagnosis of HIV infection (HIV testing is not mandatory).
- •History of another primary malignancy that is currently clinically significant or currently requires active intervention.
- •Patients with clinically suspected brain metastasis symptom, brain metastases as assessed by radiologic imaging
- •Alcohol or substance abuse disorder.
- •Known hypersensitivity to rivoceranib or any component of its formulation or history of severe hypersensitivity to including Cremophor R EL(polyoxyethylated castor oil) drug
- •Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19
- •Active bacterial infections
研究者
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