A Phase I-II Clinical Trial to Determine Recommended Dose and to Assess the Efficacy, Safety and Pharmacokinetic Profile of Oral Paclitaxel(Oraxol®) in Patients With Advanced/Metastatic or Recurrent Gastric Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Overall response rate(ORR) evaluation
研究概览
简要总结
The main objectives of this study are to determine the maximum tolerated dose (MTD) and recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of Oraxol® in Phase II.
详细描述
Administration Schedule: 1 cycle of Oraxol® is 28 days and Oraxol® is administrated twice a week, total 6 times per cycle (day 1,2,8,9,15 and 16).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must histologically or cytologically be diagnosed to have an advanced solid cancer. (phaseI)
- •Advanced/metastatic/recurred gastric cancer(PhaseII)
- •ECOG performance status ≤ 2
- •Patients have proper bone marrow, kidney, liver function and patients do not have remarkable dysfunction of heart and lung: WBC≥4000/mm3; Platelet ≥100,000/mm3; Hemoglobin≥9.0g/dL; ANC≥ 1,500 /mm3; Creatinine ≤ 1.5mg/dL; AST/ALT/ALP ≤ 3 X the upper limit of normal; Total bilirubin ≤2.0mg/dL *AST/ALT/ALP ≤ 3 X the upper limit of normal but <5 if liver or bone metastasis is present
排除标准
- •Patients with blood tumor (ex, leukemia), uncontrolled infectious disease, neurologic disorders, metastasis to CNS or ileus (patients requiring non-oral administration of anti-biotics to treat active bacterial infection are nor eligible, but patients can participate in the trial after complete eradication or control of the infection)
- •Patients who have received bone marrow transplant or are to receive bone marrow transplant.
- •Patients who had the medical history of atrial or ventricular arrhythmia or congestive heart failure or received medical treatment for myocardial infarction within 6 months.
结局指标
主要结局
Overall response rate(ORR) evaluation
时间窗: Response will be evaluated every Cycle 2(8weeks)
It is measured up to confirmation of tumor response(CR, PR) Tumor response will be evaluated by RECIST v1.0.
Toxicity evaluation (safety evaluation)
时间窗: DLT will be assessed on 28days of 1 cycle
Toxicity will be evaluated by medical history, vital signs, physical examination and laboratory tests performed during the screening period (D-28 to D0) and treatment period based on NCI-CTCAE (version 3.0).
次要结局
未报告次要终点