NCT03030066已完成1 期
A Phase 1 Study of DS-1001b in Patients With IDH1 Mutated Gliomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Percentage of participants with dose limiting toxicities
研究概览
简要总结
This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132 mutations.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has histologically confirmed glioma with an IDH1-R132 mutation
- •Has disease that has recurred or progressed following standard treatment including radiotherapy
- •Has measurable lesion(s) as per RANO criteria
- •Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
排除标准
- •Has significant symptoms of increased intracranial pressure
- •Has another active neoplasm
- •Has active infection requiring systemic treatment
- •Has a history of severe cardiac disease
- •Has had prior treatment with any inhibitor targeting mutant IDH1
- •Has had investigational drug treatment within 4 weeks prior to the first dose of study treatment
- •Is a pregnant or lactating female
研究组 & 干预措施
Experimental Drug DS-1001b
Experimental
Oral administration
干预措施: DS-1001b (Drug)
结局指标
主要结局
Percentage of participants with dose limiting toxicities
时间窗: 21 days
次要结局
- Area under the concentration curve (AUC) for DS-1001b(up to 36 months)
- Maximum plasma concentration (Cmax) for DS-1001b(up to 36 months)
- Tumor response to DS-1001b based on Response Assessment in Neuro-Oncology Criteria (RANO)(up to 36 months)
- Percentage of participants experiencing an adverse event (AE)(up to 36 months)
- Time to maximum plasma concentration (Tmax) for DS-1001b(up to 36 months)
- Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b(Baseline, up to 36 months)
研究者
研究点 (1)
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