JPRN-UMIN000020579已完成未知
An open label, non-randomized phase I/II study of ramucirumab in combination with nab-paclitaxel as second-line therapy in patients with advanced gastric cancer - A phase I/II study of ramucirumab plus nab-paclitaxel as second-line therapy in patients with advanced gastric cancer
Digestive Disease Support Organization (DDSO)0 个研究点目标入组 68 人开始时间: 2016年1月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 68
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
- 20years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. History of severe drug allergy or hypersensitivity 2. Active or uncontrolled clinically serious infection 3. Evidence of any other serious disease 4. Synchronous or metachronous malignancies other than carcinoma in situ or mucosal carcinoma 5. History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered significant) during the 3 months prior to randomization. 6. Receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents. 7. Receiving chronic therapy with nonsteroidal anti-inflammatory agents or other anti-platelet agents. Aspirin use at doses up to 325 mg/day is permitted. 8. Significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 3 months prior to study entry. 9. History of gastrointestinal perforation and/or fistulae within 6 months prior to randomization. 10. Symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia. 11. Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization. 12. Uncontrolled arterial hypertension >150/>90mmHg despite standard medical management 13. Serious or non healing wound or peptic ulcer or bone fracture within 28 days prior to randomization 14. Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohns disease, ulcerative colitis, or chronic diarrhea 15.Massive ascites, pleural effusion, or cardiac effusion 16.The patient is pregnant or breastfeeding 17. Judged inappropriate by the investigators
研究者
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