EUCTR2017-004675-31-IT进行中（未招募）1 期
A randomized Phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5-fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapy - NAPAN study
ACADEMIC MEDICAL CENTRE AMSTERDAM0 个研究点目标入组 90 人开始时间: 2021年6月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- •= 18 years of age
- •Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas
- •Documented metastatic disease
- •Previously treated with gemcitabine or gemcitabine containing therapy,
- •or progression within 6 months of adjuvant gemcitabine treatment
- •Adequate hepatic, renal and hematological function
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Any clinically significant gastrointestinal disorder, including hepaticdisorders, bleeding, inflammation, occlusion, or diarrhea > grade 2
- •Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months
- •NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically
- •significant abnormal findings
- •Active infection or an unexplained fever >38.5°C (excluding tumor fever), which in the physician's opinion might compromise the patient's
- •Current use or any use in last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors
- •Known hypersensitivity to any of the components of liposomal irinotecan (nal-IRI) other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin.
- •Hypersensitivity to any of the active substances (tegafur, gimeracil, and oteracil)
- •History of severe and unexpected reactions to fluoropyrimidine therapy
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •Breast feeding, known pregnancy, positive serum pregnancy test or unwillingness to use a reliable method of birth control, during therapy and for 3 months following the last dose of liposomal irinotecan (nal-IRI).
- •Treatment within 4 weeks with DPD inhibitors, including sorivudine or its chemically related analogues such as brivudine
研究者
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