KCT0007392尚未招募未知
A phase II study of rivoceranib in combination with paclitaxel in patients with advanced gastric and gastroesophageal junction carcinoma
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Age = 19 years of male and female
- •2) Subjects with histologically confirmed locally advanced or metastatic gastric cancer that have progressed after treatment with first-line fluoropyrimidine-based chemotherapy
- •3) Patients must have measurable disease based on RECIST 1.1
- •4) Patients must have adequate organ and marrow function
- •5) ECOG performance status 0-1
- •6) Patients with expected life expectancy of at least 12 weeks
- •7) Patients must be able to swallow and retain oral medications
- •8) Patients with no major gastrointestinal disease (e.g., chronic diarrhea) that interferes with drug absorption and no history of intestinal surgery (excluding total/partial gastric resection for gastric cancer)
- •9) Patients with the ability and willingness to comply with the study protocol during the trial period and during the course of follow-up
- •10) Patients who have signed and submitted the consent form for the study, including compliance with the research consent form and the requirements and restrictions listed in this protocol
排除标准
- •1) History of administration of taxanes (paclitaxel or docetaxel) or contraindication for paclitaxel treatment
- •2) Previous treatment with riboceranib or other systemic treatment with VEGF pathway inhibitors 3) History of another malignancy within 2 years prior to screening
- •4) Active central nervous system lesions
- •5) Therapeutic (not prophylactic) use of maximum doses of oral or parenteral anticoagulants or other thrombolytics (within 10 days prior to Day 1 of Cycle 1)
- •6) Co-administration with potent inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19
- •7) Active bacterial infections that require systemic antibiotic therapy (including tuberculosis and syphilis)
- •8) History of HIV infection
- •9) Active hepatitis B or C or chronic hepatitis B or C requiring antiviral or prophylactic antiviral therapy
- •10) Child-Pugh B or C liver dysfunction
- •11) Pregnant or lactating women or patients unwilling to comply with contraceptive requirements 12) History of uncontrolled hypertension
- •13) Symptomatic congestive heart failure (NYHA class III-IV), symptomatic and poorly controlled cardiac arrhythmias, complete left bundle branch block, bifascicular block, or clinical ST-segment and/or T-wave abnormality, QTcF>450 msec for men and QTcF>470 msec for women before screening
- •14) Clinically significant bleeding history within 14 days before Day 1 of Cycle 1
- •15) A history of clinically significant thrombosis within 3 months before the D1 of Cycle 1, which may put the patient at risk of side effects due to anti-angiogenic drugs according to the opinion of the investigator
- •16) History of other significant cardiovascular or vascular disease within 6 months prior to screening that could pose a risk to the patient due to VEGFR inhibitory therapy (e.g., myocardial infarction or unstable angina, stroke or transient cerebral ischemia, or significant peripheral vascular disease)
- •17) History of clinically significant glomerulonephritis, biopsy-proven tubulointerstitial nephritis, crystal nephropathy, or other renal failure
- •18) Psychological, familial, social, or geographic conditions (including substance abuse or alcohol abuse) that prevent compliance with trial participation or evaluation of trial results
研究者
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