JPRN-UMIN000016115已完成2 期
Phase II trial of regorafenib in patients with imatinib resistrant gastrointestinal stromal tumor - RESET for GIST
ational Cancer Center East Hospital0 个研究点目标入组 38 人开始时间: 2015年1月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
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) Serious coexisting illness as follows. a. Active double cancer(s) b. CNS metastasis c. Uncontrollable infectious disease d. Uncontrollable pleural effusion, ascites, or cardiac effusion within 2weeks prior to enrollment e. Ileus, renal failure, hepatic failure or cerebrovascular disorder within 6months prior to enrollment f. Interstitial pneumonia or pulmonary fibrosis apparent on CT g. Uncontrolled diabetes mellitus h. Uncontrolled hypertension i.Cardiac infarction, serious or unstable angina or New York Heart Association Class III or IV within 12 months prior to enrollment j Needs antiarrhythmic treatment k. Gastrointestinal bleeding within 4 weeks. l. Positive HBs antigen or HIV antibody m. Need immunosuppressive therapy n. Uncontrolled mental disease or the psychotic manifestation o. Pheochromocytoma 2) Receive the treatment as follows. a.Major surgery therapy within 4 weeks prior to enrollment. b.Chemotherapy (except Imatinib) within 3 weeks prior to enrollment. c. Imatinib within 1 week prior to enrollment. d.Wide field radiotherapy 4 weeks prior to enrollment e.Other investigational drugs within 4 weeks prior to enrollment. 3) Unrecovered AEs related to prior treatment are Grade >= 2 according to CTCAE. 4) Blood transfusion or G-CSF within 14 days prior to enrollment. 5) Gastrointestinal malabsorption 6) Serious renal failure or proteinuria >= 2+ within 7days prior to enrollment 7) Thromboembolic event within 6 months prior to enrollment 8) Untrecovered wound or traumatic fracture 9) Need anticoaglation 10) Women during pregnancy or lactation , 11) Known hypersensitivity to Regorafinib or Regorafinib's excipient 12) Tendency to hemorrhages or Grade >= 3 bleeding within 4 weeks. 13) Patient is judged by the investigator to be inappropriate for study participation for any reason.
研究者
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