NCT06622941招募中2 期
A Multicenter, Open-label, Uncontrolled Phase II Study to Investigate Efficacy and Safety of ONO4538 in Patients With Rhabdoid Tumor
Ono Pharmaceutical Co., Ltd.14 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2024年11月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 23
- 试验地点
- 14
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid Tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender: Not specified
- •Age (at the time of consent): 1 year or older
- •Patients who are refractory or intolerant to one or more regimens of chemotherapy for rhabdoid Tumors
- •Patients with advanced or recurrent rhabdoid Tumors not eligible for curative resection
排除标准
- •Patients with a history of active concurrent malignancy or complications
- •Patients with spinal lesions expected to require radiation therapy or surgical intervention during the trial period
- •Patients with concomitant central nervous system disorders other than AT/RT that are inadequately controlled or may lead to discontinuation of the investigational drug
研究组 & 干预措施
ONO-4538
Experimental
干预措施: ONO-4538 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: up to 4.5 years
次要结局
- Objective response rate (ORR) (site investigator assesment)(up to 4.5 years)
- Overall survival (OS)(up to 4.5 years)
- Progression free survival (PFS)(up to 4.5 years)
- Best reduction percent change from baseline in the sum of diameters of target lesions(up to 4.5 years)
- Disease control rate (DCR)(up to 4.5 years)
- Time to response (TTR)(up to 4.5 years)
- Best overall response (BOR)(up to 4.5 years)
- Percent change from baseline in the sum of diameters of target lesions(up to 4.5 years)
- Incidence of Adverse Events [Safety](Up to 30 days after the last dose)
研究者
研究点 (14)
Loading locations...
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