A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients With Relapsed/Refractory Neuroblastoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 71
- 试验地点
- 31
- 主要终点
- Duration of Response (DoR)
研究概览
简要总结
The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have relapsed/refractory neuroblastoma and have active disease in at least one site: bone, bone marrow or soft tissue. Participants must be able to submit an archival sample of tissue.
- •Participants must be able to swallow capsules.
排除标准
- •Participants must not have had an allogeneic hematopoietic stem cell, bone marrow, or solid organ transplant.
- •Participants must not have untreated tumor that has spread to the brain or spinal cord.
- •Participants must not have a serious active disease other than neuroblastoma.
- •Participants must not have a condition affecting absorption.
- •Participants must not have had prior aurora kinase inhibitor exposure.
- •Participants must not have a known allergy to the study treatment.
- •Participants must not have symptomatic human immunodeficiency virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.
研究组 & 干预措施
LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion
LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.
干预措施: Topotecan (Drug)
LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation
LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV).
干预措施: Cyclophosphamide (Drug)
LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion
LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.
干预措施: LY3295668 Erbumine (Drug)
LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation
LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV).
干预措施: Topotecan (Drug)
LY3295668 Erbumine Expansion
LY3295668 Erbumine given orally.
干预措施: LY3295668 Erbumine (Drug)
LY3295668 Erbumine Escalation
LY3295668 Erbumine given orally.
干预措施: LY3295668 Erbumine (Drug)
LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation
LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV).
干预措施: LY3295668 Erbumine (Drug)
LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion
LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Duration of Response (DoR)
时间窗: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years)
DoR
Number of Participants with Dose Limiting Toxicities (DLTs)
时间窗: Baseline through Cycle 2 (28 Day Cycle)
Number of Participants with DLTs
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
时间窗: Baseline through Measured Progressive Disease (Estimated up to 5 Years)
ORR
次要结局
- Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)(Baseline to Date of Objective Disease Progression (Estimated up to 5 Years))
- Overall Survival (OS)(Baseline to Date of Death from Any Cause (Estimated up to 6 Years))
- Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668(Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles))
- PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide(Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles))
- Progression-Free Survival (PFS)(Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years))