ISRCTN13413322已完成不适用
A multinational, multicenter, open-label, controlled, randomised, parallel group study to evaluate the efficacy and safety of EMD 121974 and gemcitabine or gemcitabine alone in patients with advanced, unresectable pancreatic cancer
Merck KGaA (Germany)0 个研究点目标入组 60 人开始时间: 2006年3月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 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
入排标准
- 性别
- All
入选标准
- •1. The patient must have provided written informed consent prior to any study-related procedure
- •2. The patient must be at least 18 years of age
- •3. The patient must be male or female without childbearing potential (i.e. post-menopausal or sterile)
- •4. The patient must suffer from histologically confirmed advanced unresectable pancreatic cancer with or without metastases
- •5. The patient must have at least one bidimensionally measurable or evaluable lesion
- •6. The life expectancy of the patient must be at least 12 weeks
- •7. The patient must have a Karnofsky performance score of = 70%
- •8. Outpatients as well as inpatients can be selected for this study
排除标准
- •1. In the investigator?s opinion, if the patient is not able to comply with the protocol regulations
- •2. The patient is a pregnant or lactating female. Females with childbearing potential are generally excluded from the study.
- •3. The patient has received chemotherapy, and/or major surgery related to the pancreatic cancer prior to study entry. Palliative surgeries (e.g. for the placement of stents) or explorative laparotomies do not fall into this category.
- •4. The patient has received prior antiangiogenic therapy
- •5. The patient?s laboratory parameters lie within the following ranges: pre-treatment granulocytes <1500 /ml, haemoglobin <9 g/dl, platelet count <100,000 /ml, pre-treatment bilirubin >3 times the upper limit of normal, pre-treatment creatinine >2 times the upper limit of normal
- •6. The patient?s liver transaminases lie within the following ranges: serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) >5 times the upper limit of normal
- •7. The patient has had a second primary malignancy within the past five years except carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin
- •8. The patient has a history of brain metastases. In case of suspected brain metastases, a computer tomography (CT) scan of the skull will be performed. This is not mandatory in asymptomatic patients.
- •9. The patient has had a major surgery within four weeks of study entry
- •10. The patient has a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- •11. The patient has had bypass surgery within six months of study entry, or has clinically significant cardiac or cardiovascular abnormalities (New York Heart Association [NYHA] III/IV) or unstable angina or arrhythmias (Lown class IV) requiring treatment
- •12. The patient has abnormal clotting disorders as defined by international normalized ratio (INR) >1.5, prothrombin time >18 seconds or activated partial thromboplastin time (APTT) >60 seconds, or patients on anticoagulant therapies. Migratory thrombophlebitis does not fall into this category.
- •13. The patient is suffering from severe diabetic angiopathy due to a long history of diabetes mellitus
- •14. The patient has had gastric or duodenal ulcers within six months of study entry, or is at risk of gastrointestinal ulceration due to a high consumption of non-steroidal anti-inflammatory drugs (NSAIDs)
- •15. The patient has a known active infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV)
- •16. The patient is suffering from serious uncontrolled infections
- •17. The patient has a history of allergies against penicillin
- •18. The patient has a legal incapacity or a limited legal capacity
- •19. The patient is known for drug abuse or extensive chronic use of alcohol
- •20. The patient takes or is likely to need prohibited concomitant medication
- •21. The patient has participated in another clinical study within 30 days of study entry
- •22. Fertile men not willing to use contraception
研究者
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