A Phase 1b Study of Aurora A Kinase Inhibitor LY3295668 Erbumine in Monotherapy and Combination Therapy in Patients With Metastatic Breast Cancer Post CDK4/6 Inhibitor and Endocrine Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 7
- 主要终点
- Part II: Number of Participants with Dose Limiting Toxicities (DLTs)
研究概览
简要总结
The reason for this study is to determine the recommended phase 2 dose of the study drug LY3295668 erbumine in participants with breast cancer that has spread to other parts of the body.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant must have hormone receptor positive and HER2 negative metastatic breast cancer
- •Participant must have progressed on at least 1 line of endocrine therapy and 1 cyclin dependent kinase (CDK)4/6 inhibitor
- •Participant must be able and willing to undergo mandatory tumor biopsy
- •Participant must have normal organ function
- •Participant must be able to swallow capsules
排除标准
- •Participant must not have had prior chemotherapy for mBC. Chemotherapy in the adjuvant/neoadjuvant setting is permitted
- •Participant must not be currently enrolled in a clinical study
- •Participant must not have another serious medical condition
- •Participant must not have previously received an aurora kinase inhibitor
研究组 & 干预措施
LY3295668 Erbumine Part A
LY3295668 erbumine administered orally (Part I).
Approximately the first 10 participants enrolled in this arm will be administered midazolam.
干预措施: LY3295668 Erbumine (Drug)
LY3295668 Erbumine Part A
LY3295668 erbumine administered orally (Part I).
Approximately the first 10 participants enrolled in this arm will be administered midazolam.
干预措施: Midazolam (Drug)
LY3295668 Erbumine Part B
LY3295668 erbumine administered orally (Part I).
Approximately the first 10 participants enrolled in this arm will be administered midazolam.
干预措施: LY3295668 Erbumine (Drug)
LY3295668 Erbumine Part B
LY3295668 erbumine administered orally (Part I).
Approximately the first 10 participants enrolled in this arm will be administered midazolam.
干预措施: Midazolam (Drug)
LY3295668 Erbumine + Endocrine Therapy Cohort 1
LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II).
干预措施: LY3295668 Erbumine (Drug)
LY3295668 Erbumine + Endocrine Therapy Cohort 1
LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part II).
干预措施: Endocrine therapy (Drug)
LY3295668 Erbumine + Endocrine Therapy Continuation Part C
LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
干预措施: LY3295668 Erbumine (Drug)
LY3295668 Erbumine + Endocrine Therapy Continuation Part C
LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
干预措施: Endocrine therapy (Drug)
LY3295668 Erbumine + Endocrine Therapy Switch Part D
LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
干预措施: LY3295668 Erbumine (Drug)
LY3295668 Erbumine + Endocrine Therapy Switch Part D
LY3295668 erbumine administered orally and endocrine therapy administered according to package label (Part I).
干预措施: Endocrine therapy (Drug)
结局指标
主要结局
Part II: Number of Participants with Dose Limiting Toxicities (DLTs)
时间窗: Baseline through Cycle 1 (28 Day Cycle)
Part II: Number of Participants with DLTs
Number of Participants with Dose Reductions
时间窗: Baseline through Cycle 1 (28 Day Cycle)
Number of Participants with Dose Reductions
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 23 Months)
ORR
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 23 Months)
DoR
次要结局
- Progression-Free Survival (PFS)(Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 23 Months))
- PK: AUC of LY3295668 in Combination with Endocrine Therapy(Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles))
- PK: AUC of Endocrine Therapy in Combination with LY3295668(Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles))
- PK: AUC of Midazolam(Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles))
- PK: AUC of Midazolam in Combination with LY3295668(Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles))
- Clinical Benefit Rate (CBR): Percentage of Participants Who Achieve CR, PR or SD With a Duration of At Least 6 Months(Baseline through Disease Progression or Death Due to Any Cause (Estimated up to 23 Months))
- Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668(Predose Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles))