NL-OMON55645招募中2 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 - Second line treatment with nal-IRI and S1 in pancreatic cancer.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Able to understand and provide written informed consent
- •>= 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
排除标准
- •Any clinically significant gastrointestinal disorder, including hepatic
- •disorders, 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 health
- •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
- •Previous treatment with 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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