EUCTR2007-007476-42-BE进行中（未招募）不适用
A phase II study of CP-4126 in patients with advanced pancreatic cancer - CP4126-201
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histological or cytological confirmed advanced pancreatic cancer
- •2. Not eligible for curative resection
- •3. Previously untreated with chemotherapy for advanced disease
- •4. Karnofsky Performance status (PS) of at least 50
- •5. Estimated life expectancy of at least 12 weeks
- •6. Age = 18 years
- •7. Adequate haematological and biological functions:
- •Bone marrow function:
- •a. Neutrophils = 1.5 x 109/L
- •b. Platelets > 100.0 x 109/L
- •c. Hb = 10 g/dL
- •Hepatic function:
- •a. 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
- •b. Bilirubin = 1.5 times institutional ULN, if liver metastases = 3 x institutional ULN
- •Renal function:
- •a. Serum creatinine = 1.5 times institutional ULN
- •8. Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior chemotherapy for metastatic disease
- •2. Symptomatic brain metastases
- •3. Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
- •4. Requirement of concomitant treatment with a non-permitted medication, including high doses of vitamins and alternative drugs
- •5. History of allergic reactions to gemcitabine or egg
- •6. Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection)
- •7. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance
- •8. Pregnant or breastfeeding women
- •9. 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
- •10. Known positive status for HIV and/or hepatitis B or C
- •11. Any reason why, in the investigator’s opinion, the patient should not participate in the study.
- •12. Drug or alcohol abuse
- •13. Prior radical resection is not allowed, but exploratory laparotomy as well palliative (e.g. bypass) surgery are allowed
研究者
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