JPRN-jRCT2080223424已完成1 期
A Phase 1 Study of DS-1001b in Patients with IDH1 Mutated Gliomas
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Subjects must have histologically confirmed glioma with an IDH1-R132 mutation.
- •2) Subjects must have disease that has recurred or progressed following standard treatment including radiation therapy.
- •3) Subjects must have measurable lesion(s) as per RANO criteria.
- •4) Subjects must have ECOG PS of 0 to 2.
排除标准
- •1) Subjects with significant symptoms of increased intracranial pressure.
- •2) Subjects who have active another neoplasm.
- •3) Subjects with active infection requiring systemic treatment.
- •4) Subjects with a history of severe cardiac disease
- •5) Subjects who have received prior treatment with any therapy targeting mutant IDH1.
- •6) Subjects who have received other investigational drug treatment within 3 weeks prior to the first dose of study treatment.
- •7) Female subjects who are pregnant or breast feeding.
研究者
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