EUCTR2021-004734-11-DE进行中（未招募）1 期
A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination with Irinotecan and Temozolomide in Participants with Relapsed or Refractory Ewing's Sarcoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
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
- 性别
- All
入选标准
- •- Diagnosis of Ewing’s sarcoma or Ewing’s sarcoma-like tumor
- •- Confirmed radiological progression or refractory disease or recurrence
- •following first or later line of treatment of Ewing's sarcoma or Ewing's
- •sarcoma-like tumor, and must have one measurable or evaluable lesion per RECIST 1.1
- •- Participants aged 1 to <40 years
- •- Body weight =10 kg
- •- Adequate performance status based on age. For participants <16 years of age, a Lansky score =50, or for participants =16 years of age, a Karnofsky score =50
- •- The participant has adequate hematologic and organ function =14 days prior to Day 1 of
- •- Must be able to swallow and/or have a gastric/nasogastric tube. Participants in the European Union must be able to swallow intact capsules.
- •- Discontinued all previous treatments for cancer or investigational agents and recovered from the acute effects to Grade =1 at the time of enrollment
- •- Female patients of childbearing potential must have a negative urine or
- •serum pregnancy test within 7 days prior to Cycle 1 Day 1. For France,
- •serum pregnancy test must be performed.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 13
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Have received any prior CDK4 and 6 inhibitor
- •- Progression during prior treatment with irinotecan or temozolomide
- •- Currently enrolled in a clinical study involving an investigational product, or any other type of medical research judged not to be scientifically or medically compatible with this study
- •- A serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
研究者
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