NCT00913198已完成2 期
A Phase II Study of CP-4126 in Patients With Advanced Pancreatic Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Biological activity of CP-4126 in patients with advanced pancreatic cancer.
研究概览
简要总结
The main objective of this study is to assess the biological activity of CP-4126 in patients with advanced pancreatic cancer. In addition, the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival will be studied.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological confirmed advanced pancreatic cancer*
- •Not eligible for curative resection
- •Performance Status (ECOG) 0-2
- •Estimated life expectancy of at least 12 weeks
- •Age ≥ 18 years
- •Adequate haematological and biological functions:
- •Neutrophils ≥ 1.5 x 109/L
- •Platelets > 100.0 x 109/L
- •Hb ≥ 10 g/dL
- •AST/ALT and alkaline phosphatase (ALP) ≤ 2.5 x institutional upper limit of normal (ULN), if liver metastases
- •AST/ALT ≤ 5 x institutional ULN and ALP ≤ 4 x institutional ULN
- •Bilirubin ≤ 1.5 times institutional ULN, if liver metastases ≤ 3 x institutional ULN
- •Serum creatinine ≤ 1.5 times institutional ULN
- •Signed informed consent
排除标准
- •Prior chemotherapy for metastatic disease
- •Symptomatic brain metastases
- •Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
- •Requirement of concomitant treatment with a non-permitted medication, including high doses of vitamins and alternative drugs
- •History of allergic reactions to gemcitabine or egg
- •Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
- •Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient's compliance
- •Pregnant or breastfeeding women
- •Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for three months after last treatment
- •Known positive status for HIV
- •Any reason why, in the investigator's opinion, the patient should not participate in the study.
- •Drug or alcohol abuse
- •Prior radical resection, but exploratory laparotomy as well palliative (e.g bypass) surgery are allowed
研究组 & 干预措施
IV CP-4126
Experimental
干预措施: IV CP-4126 (Drug)
结局指标
主要结局
Biological activity of CP-4126 in patients with advanced pancreatic cancer.
时间窗: Every second cycle
次要结局
- Overall survival, Objective response rate.(Every second cycle - study length)
研究者
研究点 (3)
Loading locations...
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