jRCT2051200105招募中不适用
Phase I / IIa, single-institution, open-label study to explore the safety and efficacy of R-OKY-034F long-term administration in patients with refractory / intolerable and surgically unresectable pancreatic cancer with standard chemotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients who are 20 years old or above at the time of informed consent
- •Patients with the ECOG performance status of 0 to 2 at the time of informed consent
- •Patients with a life expectancy of at least 90 days from the day of enrollment
- •Patients with a measurable lesion defined by the criteria of the RECIST version 1.1 according to the imaging during screening period
- •Patients judged by the (sub)investigator for whom the treatment may be continued R-OKY-034F-101 study
排除标准
- •Patients with active duplicate cancer
- •Patients with QTcE of over 500 msec
- •Patients weighing less than 40 kg at the time of informed consent
- •Patients who are considered inappropriate as a subject of this study by the (sub)investigator
结局指标
主要结局
-
Adverse Event and Side Effect
次要结局
- Objective response rate
- Disease control rate
研究者
相似试验
已完成
1 期
Phase I / IIa, single-institution, open-label study to explore the safety and efficacy of R-OKY-034F in patients with refractory / intolerable and surgically unresectable pancreatic cancer with standard chemotherapyPancreatic cancerJPRN-UMIN000036395Osaka University Hospital30
进行中（未招募）
不适用
TK-042 Phase III Clinical Study
Long-term administration study in children with perennial allergic rhinitisperennial allergic rhinitisjRCT2031240126Teikoku Seiyaku Co., Ltd.60
已完成
1 期
Phase I/II clinical trial of immunoRFA with OK-432 for patients with lung cancerlung cencer(lung neoplasms)JPRN-UMIN000007167Osaka City University, Department of Diagnostic and Interventional Radiology, Japan36
已完成
2 期
Testing the Safety and Preliminary Efficacy of the New Drug ORY-2001 in Mild to Moderate Alzheimer's DiseaseMild to Moderate Alzheimer's DiseaseNCT03867253Oryzon Genomics S.A.24
未知
3 期
MK-0431/ONO-5435 Phase III Clinical Study - Long-term Treatment Study for Patients with Type 2 Diabetes MellitusType 2 Diabetes MellitusJPRN-jRCT2080220289ONO PHARMACEUTICAL CO.,LTD.