NCT03514407终止1 期
An Open-Label Phase 1b Study of the Safety, Tolerability, and Preliminary Antitumor Activity of INCB059872 in Participants With Relapsed or Refractory Ewing Sarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 11
- 主要终点
- Number of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and preliminary antitumor activity of INCB059872 in participants with Ewing sarcoma who are refractory or relapsed from prior standard therapy and not eligible for further standard systemic therapy.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of Ewing sarcoma and have progressed on or after standard therapies.
- •Must not be a candidate for potentially curative therapy or standard-of-care approved therapy.
- •Measurable disease by computed tomography or magnetic resonance imaging based on RECIST 1.1 as determined by site radiology.
- •Eastern Cooperative Oncology Group performance status 0 to
- •Willingness to avoid pregnancy or fathering children.
排除标准
- •Receipt of anticancer medications, anticancer therapies, or investigational drugs within protocol-defined intervals before the first administration of study drug.
- •Must have recovered (≤ Grade 2 or at pretreatment baseline) from adverse events (AEs) from previously administered therapies except for stable chronic toxicities (≤ Grade 2) not expected to resolve.
- •Untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed.
- •Prior radiotherapy within 2 weeks of study treatment. A 1-week washout period is permitted for palliative radiation to non-CNS disease with medical monitor approval.
- •Laboratory values outside the protocol-defined range at screening.
- •History or evidence of bleeding disorder or active clinically significant bleeding requiring medical intervention.
研究组 & 干预措施
INCB059872
Experimental
INCB059872
干预措施: INCB059872 (Drug)
结局指标
主要结局
Number of adverse events
时间窗: Screening through 30 days after last dose of study treatment, up to approximately 6 months.
Defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a drug in humans, whether or not considered drug-related.
次要结局
- Objective response rate(Up to approximately 6 months.)
- Cmax of INCB059872(Up to approximately 2 weeks.)
- tmax of INCB059872(Up to approximately 2 weeks.)
- Cl/F of INCB059872(Up to approximately 2 weeks.)
- t½ of INCB059872(Up to approximately 2 weeks.)
研究者
研究点 (11)
Loading locations...
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