NCT01218880Unknown1 期
Phase I Study of M2ES Combined Gemcitabine in Patients With Advanced Pancreatic Cancer
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
- 21
- 试验地点
- 1
- 主要终点
- Maximum tolerant dose
研究概览
简要总结
Phase I trail will be conducted to evaluate the safety of M2ES in combination with gemcitabine in locally advanced or metastatic pancreatic cancer.
详细描述
Phase I trail will be conducted to determine the MTD and safety of M2ES(administered intravenous infusion on Days 1,8,15,21of a 28-day cycle) in combination with gemcitabine (1000 m/m2). Gemcitabine will be administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle,at the same time determine the safety and efficiency of this combined regime.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients had histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery.
- •No prior chemotherapy was allowed.
- •Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port.
- •18 to 60 years of age
- •Karnofsky performance status (KPS) of 60-100 points
- •Unidimensionally 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 ≥4×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥ 9g/dL, total bilirubin ≤2 upper limit of normal [ULN],AST ≤ 1.5 ULN, or ≤ 3 ULN if there was evidence of liver metastases; alkaline phosphatase ≤ 1.5 ULN, or ≤ 3 ULN if there was evidence of liver Metastases; creatinine clearance ≥50 mL/min.
- •life expectancy of at least 12 weeks.
- •All patients provided written informed consent according to federal and institutional guidelines.
排除标准
- •patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, 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 4 weeks intervals between the last administration of the targeted therapy regimen and study entry.
- •radiation therapy have not been completed 4 weeks before enrollment.
- •major surgery within the prior 4 weeks;
- •participating any clinical trial within the prior 4 weeks;
- •Pregnant or lactating women.
- •tumor involvement of major blood vessels
- •uncontrolled intercurrent illness as following: prior or ongoing uncontrolled hypertension;angina pectoris; congestive cardiac failure; myocardial ischemia, infarction, uncompensated coronary artery disease within the past 6 months; Uncontrolled arrhythmia; Uncontrolled diabetes mellitus; Uncontrolled infection.
- •chronic renal disease.
- •urine protein ≥ 500 mg in 24 hours;
- •prior history of gastrointestinal bleeding, hemoptysis, bleeding diathesis.
- •pulmonary embolus, or deep venous thrombosis
- •ECG: QTC ≥ 480 ms
- •Patients on therapeutic doses of heparin or antiplatelet agents.
- •Patients who received thrombolytic agents or who required full-dose anticoagulation
研究组 & 干预措施
M2ES-A
Experimental
干预措施: M2ES 7.5mg (Drug)
M2ES-B
Experimental
干预措施: M2ES 15mg (Drug)
M2ES-C
Experimental
干预措施: M2ES 30mg (Drug)
M2ES-D
Experimental
干预措施: M2ES 45mg (Drug)
结局指标
主要结局
Maximum tolerant dose
时间窗: 8 week
次要结局
- objective response rate(8 weeks)
研究者
研究点 (1)
Loading locations...
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