NCT04458272进行中（未招募）2 期
A Phase II Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-naive IDH1 Mutated WHO Grade II Glioma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 11
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs) during the study
研究概览
简要总结
This Phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.
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 a histopathologically documented IDH1 mutated WHO grade II glioma according to the 2016 WHO classification.
- •Has confirmed IDH1 mutation at the R132 locus by testing at the central laboratory conducted during the screening period.
- •Has no prior anticancer treatment (including chemotherapy and radiotherapy) for glioma except craniotomy or biopsy.
- •Has at least 1 measurable and non-enhancing lesion.
- •Has an interval of at least 90 days from the latest surgery.
- •Has no sign of malignant transformation including the appearance of enhancing lesions and/or rapid growth of non-enhancing lesions.
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.
排除标准
- •Has had a histopathological diagnosis of WHO grade III or IV glioma.
- •Has had a contrast enhancing lesion on brain MRI.
- •Has received a prior treatment with any mutant IDH1 inhibitor.
- •Has received other investigational products within 28 days before the start of the study drug treatment.
- •Has an active infection requiring systemic treatment.
- •Has multiple primary malignancies.
- •Has a history of clinically significant cardiac disease.
- •Is a pregnant or lactating woman.
研究组 & 干预措施
DS-1001b
Experimental
干预措施: DS-1001b (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs) during the study
时间窗: Up to 24 months
Overall response rate (ORR) assessed by Independent Efficacy Review Committee
时间窗: Up to 24 months
次要结局
- Overall survival(Through the end of the study (up to approximately 6 years))
- Time to maximum plasma concentration (Tmax) for DS-1001a(Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days))
- Maximum plasma concentration (Cmax) for DS-1001a(Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days))
- Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b(Through the end of the study (up to approximately 6 years))
- Clinical benefit rate(Through the end of the study (up to approximately 6 years))
- Percentage change in tumor volume(Through the end of the study (up to approximately 6 years))
- Time to response(Through the end of the study (up to approximately 6 years))
- Area under the concentration curve (AUC) for DS-1001a(Cycle 1 Day 1 to Cycle 13 Day 1 (each cycle is 28 days))
- Duration of response(Through the end of the study (up to approximately 6 years))
- Time to treatment failure(Through the end of the study (up to approximately 6 years))
- Progression-free survival(Through the end of the study (up to approximately 6 years))
研究者
研究点 (11)
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