JPRN-jRCT2031210121招募中1 期
A Phase 1b/2, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anticancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreaK 101)
akatani iwami0 个研究点目标入组 1,143 人开始时间: 2021年5月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,143
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
- >= 18age old 至 <= 100age old（—）
- 性别
- All
入选标准
- •Men or women greater than or equal to 18 years old.
- •- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
排除标准
- •- Primary brain tumor.
- •- Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
- •- Myocardial infarction within 6 months of study day 1.
- •- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
研究者
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