JPRN-UMIN000009603招募中2 期
Phase II study evaluating Erlotinib/Bevacizumab therapy as a second line therapy for advanced relapsed EGFR mutation positive non-squamous NSCLC patients who received first line combination therapy including platinum and Bevacizumab - Phase II study evaluating Erlotinib/Bevacizumab therapy as a second line therapy for advanced relapsed EGFR mutation positive non-squamous NSCLC patients who received first line combination therapy including platinum and Bevacizumab
Respiratory Center, Showa University Northern Yokohama Hospital0 个研究点目标入组 13 人开始时间: 2012年12月21日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 13
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 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Patients treated with EGFR-TKI 2. Patients with T790M mutation 3. Patients with history or combination of interstitial lung disease (interstitial pneumonia, pneumonitis, radiation pneumonia, BOOP, pulmonary fibrosis, ARDS, pulmorary infiltration, alveolitis, etc), and lung infection 4. Patients complicated with corneal disease, which is a problem in the clinical 5. Patients with intestinal diverticulitis 6. Patients with symptomatic brain metastases 7. Patients with history or complication of hemoptysis *Definition of hemoptysis is determined as the following. A history of continuous hemoptysis over one week, or hemoptysis receiving oral or intravenous hemostatic medicine 8. Patients with a history of severe drug allergy 9. Patients with uncontrolled ascites, pleural effusion, or pericardial effusion 10. Patients with a history of gastrointestinal perforation within an year, or a complication of uncontrollable peptic ulcer 11. Patients with uncontrolled hypertension 12. Patients with infectious disease requiring systemic administration of antiviral agents, antifungal agents, or antibiotics 13. Patients receiving antiplatelet therapy *Patients receiving aspirin therapy up to 325mg are allowed to be registered 14. Patients with a history of radiation to the chest, or more than 20% region of bones with hematopoietic ability 15. Patients with multiple cancers within 5 years prior to initiation of the study, except for carcinoma in situ, mucosal cancer appropriately treated non-melanoma, cervical cancer, thyroid cancer, early gastric cancer, early colorectal cancer 16. Patients with serious complications (such as heart disease, active infection, interstitial pneumonia, diabetes) 17. Pregnant woman or those with suspected pregnancy, nursing woman and those who plan to become pregnant during the study period 18. Other patients whom the investigator considers to be unsuitable for participation in the study
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