jRCT2080225089已完成1 期
Phase 1, Open-Label, First-in-Human Study of DS-6157a in Subjects with Advanced Gastrointestinal Stromal Tumor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Dose Escalation Part
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multi Center, Open-label
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Dose Escalation (Part 1): subjects should meet one of the following criteria:
- •a. (For US sites only) Subjects with GIST who have progressed on, or are intolerant to, imatinib (IM) and at least one post-IM treatment, or who are not candidates for post-IM standard of care treatment
- •b. (For Japan sites only) Subjects with GIST who have received all the existing standard of care treatments or who are not candidates for one or more available post-IM standard of care treatments
- •c. Subjects with GIST who are not candidates for IM or curative intent surgical treatment
- •Dose Expansion (Part 2) Cohort 1: subjects with GIST who have progressed on or are intolerant to IM and at least one post-IM treatment
- •Dose Expansion (Part 2) Cohort 2: subjects with GIST who have progressed on IM and had not received a post-IM treatment (2nd line)
- •LVEF >= 50% .
- •Has an ECOG PS 0-
- •Is aged >=20 years old in Japan or >=18 years old in other countries
排除标准
- •Has a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety, efficacy, or any other assessments of the investigational regimen
- •Has a documented history of myocardial infarction or unstable angina within 6 months before study treatment
- •Has clinically significant pulmonary compromise or requirement for supplemental oxygen
结局指标
主要结局
Dose Escalation Part
To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of DS-6157a.
Dose Expansion Part
To investigate the safety, tolerability and efficacy of DS-6157a.
次要结局
- pharmacokinetics
- efficacy
- other
研究者
研究点 (1)
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