JPRN-UMIN000020773已完成2 期
Phase II study assessing the efficacy and safety of lenvatinib for anaplastic thyroid cancer (HOPE) - HOPE
Translational Research Informatics Center, Foundation for Biomedical Research and Innovation0 个研究点目标入组 39 人开始时间: 2016年1月28日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
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) Have complications or medical history of (a) Complication of brain metastasis (Exclude if cured and in clinically stable condition for more than 1 month prior to screening.) (b) Treatment required complication of systemic infectious disease (c) Complication of pulmonary fibrosis or interstitial pneumonitis (d) Medical history of clinically significant cardiovascular disease within 6 months of initial dose as: NYHA class above 2 leveled congestive heart failure, unstable angina, cardiac infarction or cardiac arrhythmia with paroxysmal or required treatment e) Uncontrollable complication of diabetes mellitus f) hemoptysis within 3 weeks of enrollment (blood volume of more than half of teaspoon) g) Medical history of hemorrhagic or thrombotic disease within 6 months of enrollment h) If proteinuria values above 2+ by urinary protein qualitative test, conduct 24-hour urine collection and the urine protein determined as 1g/24 hours or more. (can substitute to the ratio of proteinuria in morning urine/creatinine) i) Malabsorption at gastrointestinal tract and any of the complication diseases that investigator considers that will be affected to lenvatinib absorption j) Recent major surgery within 2 weeks (if needle biopsy within 1 week) of enrollment k) Drainage required celomic fluid stagnation 2) Have history of lenvatinib administration 3) Confirmed tumor invasion to the carotid arteries 4) Have history of high dose external radiation therapy to cervical region, and irradiated tumor location close to the carotid arteries. 5) Have any unresolved toxicity greater than 1 by CTCAE v4.0. 6)Have active double cancer 7) Female patients who are pregnant, lactating, breast feeding or have childbearing potential 8) Psychiatric disorder and regarded by the investigator as inadequate for this study enrollment 9) Confirmed as no resistance to any component of this drug 10) Currently receiving other interventional clinical study treatment
研究者
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