NCT02381886进行中（未招募）1 期
A Phase I Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 166
- 试验地点
- 21
- 主要终点
- Incident rate of dose limiting toxicities (DLTs)
研究概览
简要总结
A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented IDH1R132-mutant tumors
- •ECOG performance status ≤ 2
排除标准
- •Patients who have received prior treatment with a mutant-specific IDH1 inhibitor (with the exception of glioma patients)
- •Medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease.
- •Acute Promyelocytic Leukemia
- •Women who are pregnant or lactating
- •Other protocol-defined Inclusion/Exclusion may apply
研究组 & 干预措施
IDH305
Experimental
干预措施: IDH305 (Drug)
结局指标
主要结局
Incident rate of dose limiting toxicities (DLTs)
时间窗: 21 days
To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)
次要结局
- Incidence of adverse events (AEs)(30 months)
- Incidence of serious adverse events (SAE)(30 months)
- Plasma PK parameters (AUC, Cmax, Tmax)(30 months)
- Changes of 2-hydroxyglutarate concentration in patient specimens(30 months)
- Overall response rate (ORR)(30 months)
研究者
研究点 (21)
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