JPRN-UMIN000008336已完成1 期
Phase1 Clinical Trial of OTS102 in Subjects with Solid Tumors - Phase1 Clinical Trial of OTS102 in Subjects with Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
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)symptomatic brain metastasis 2)pleural effusion, ascites fluid, pericardial fluid requiring drenege 3)Unhealed traumatic lesion 4)Hemorrhagic diathesis or severe coagulopthy, and patients with those histories 5)hemoptysis or lung hemorrhage or gastrointestinal bleeding, and patients with those histories 6)uncontrolled hypertension (systolic:140 mmHg and over, diastolic: 90 mmHg and over), or serious arrhythmia or heart failure 7)serious complication, equivalent to CTCAE grade 3 or greater 8)Patients who require systemic administration of the following agents during OTS102 study medication period. -Corticosteroid, Anticoagulant drug, Immunosuppresant, Immunostimulant -Granulocyte Colony Stimulating Factor (G-CSF), Granulocyte, Macrophage Colony Stimulating Factor (GM-CSF), Erythropoietin (EPO) 9)Participating in drug clinical trials 10)Woman who is pregnant, breast feeding and child-bearing potential. 11)Patient or patient's partner unwilling to use adequate contraception. 12)As determined by the principal investigator or the sub-investigator the subject has difficulties that would prevent the subject's ability to participate in the trial.
研究者
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