JPRN-UMIN000018968已完成未知
Phase II dose titration study of regorafenib for patients with unresectable metastatic colorectal cancer who are progressed after standard chemotherapy - Phase II dose titration study of regorafenib for patients with unresectable metastatic colorectal cancer who are progressed after standard chemotherapy
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group0 个研究点目标入组 60 人开始时间: 2015年9月10日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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) Prior treatment with regorafenib. 2) Previous or concurrent cancer that is distinct in primary site or histology form colorectal cancer within 5 years prior to randomization EXCEPT for curatively treated cervicalcancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta, Tis and T1]. 3) Major surgical procedure within 28 days before start of study medication. 4) Pregnant or breast-feeding patients. Woman of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment, and a negative result must be documented before start of treatment. 5)Congestive heart failure >=NYHA class 2. 6) Unstable angina, new-onset angina. Myocardial infarction less than 6 months before start of study medication. 7)Uncontrolled hypertension. 8) Pleural effusion or ascites with dyspnea higher than CTCAE v4.0 grade 2. 9) Arterial or venous thrombotic or embolic events such as cerebrovascular accident, deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication. 10) Known history of HIV infection, or chronic hepatitis B or C. 12) Symptomatic metastatic brain or meningeal metastasis. 13) Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event >= CTCAE v4.0 Grade 3 within 4 weeks of start of study medication. 14) Interstitial lung disease with ongoing sings and symptoms at the time of informed consent. 15) Persistant proteinuria of CTCAE v4.0 Grade 3 or higher. 16) Patients unable to swallow oral medications. 17) Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation. 18) Non-healing wound, ulcer, or bone fracture. 19) Unsolved toxicity higher than CTCAE v4.0 Grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity <= Grade 2
研究者
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