NCT01219192Unknown1 期
Phase I Study of M2ES in Patients With Advanced Pancreatic Cancer After Gemcitabine Treatment Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- Protgen Ltd
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- MDT
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability and determine the recommended dosing for the treatment in patients with advanced pancreatic cancer after fist-line Gemcitabine treatment failure.
详细描述
To evaluate the safety and tolerability and determine the recommended dosing for the treatment in patients with advanced pancreatic cancer after fist-line Gemcitabine treatment failure.We star with the dose M2ES 15mg,then escalate to 30mg 45mg 60mg,to find the recommended dose in clinic practise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery.
- •All patients must have developed progressive disease (PD) while receiving or within 6 months after discontinuing palliative gemcitabine-based chemotherapy
- •Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port.
- •18 years of age or older
- •Karnofsky performance status (KPS) of 60-100 points
- •measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- •Adequate hematologic, renal, and hepatic function was required as deWned by the following: WBC ≥3.5×109/L, absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥100 × 109/L, hemoglobin≥9g/dL, total bilirubin ≤2.5 upper limit of normal [ULN],AST≤2.5 ULN, or≤5 ULN if there was evidence of liver metastases;alkaline phosphatase≤ 2.5 ULN, or≤ 5 ULN if there was evidence of liver Metastases creatinine clearance≤50 mL/min,
- •life expectancy of at least 12 weeks
排除标准
- •patients had clinically apparent CNS metastases or carcinomatous meningitis
- •another active malignancy, or any history of other malignancy within the past 5 years except for nonmelanoma skin cancer and carcinoma in situ of the cervix
- •more than 3 weeks intervals between the last administration of the prior chemotherapy regimen and study entry
- •more than 4 weeks intervals between the last administration of the targeted therapy regimen and study entry
- •major surgery within the prior 6 weeks;
- •Pregnant or lactating women
- •tumor involvement of major blood vessels
- •uncontrolled intercurrent illness
- •A history of myocardial infarction or stroke within the last 6 months, uncontrolled hypertension, unstable angina
- •clinically significant cardiac disease (eg, congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication, or myocardial infarction)
- •urine protein ≥ 500 mg in 24 hours;
- •evidence of bleeding diathesis or coagulopathy
- •Patients on therapeutic doses of low-molecular weight heparin
- •Patients who received thrombolytic agents within the previous month or who required full-dose anticoagulation.
研究组 & 干预措施
M2ES 15mg
Experimental
干预措施: M2ES (Drug)
M2ES 30mg
Experimental
干预措施: M2ES (Drug)
M2ES 45mg
Experimental
干预措施: M2ES (Drug)
M2ES 60mg
Experimental
干预措施: M2ES 60mg (Drug)
结局指标
主要结局
MDT
时间窗: 3 weeks
The maximum tolerable dosage
次要结局
- PFS(4 months)
研究者
研究点 (1)
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