A Phase 1 Dose-Escalation Study of LY2606368 in Combination With Ralimetinib in Patients With Advanced or Metastatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib
研究概览
简要总结
The main purpose of this study is to evaluate the safety of the study drug prexasertib in combination with ralimetinib in participants with advanced or metastatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced or metastatic cancer.
- •Able to swallow tablets.
- •For Part B, you will need to have colon cancer or non-small cell lung (NSCLC) cancer with KRAS and/or BRAF mutations.
- •Discontinued all previous treatments for cancer and recovered from the acute effects from the therapy.
排除标准
- •Active infection (fungal, viral, or bacterial).
- •Active cancer in your brain or spinal cord.
- •Acute or chronic leukemia.
- •Serious heart condition.
- •Disease that requires immunosuppressant therapy.
- •Diagnosis of inflammatory bowel disease.
- •Major small bowel resection that interferes with your body's ability to absorb the oral medicine.
- •Participated in other clinical trials investigating prexasertib or ralimetinib.
- •Pregnant or breastfeeding.
- •Other pre-existing conditions or medical history which your doctor will explain to you.
研究组 & 干预措施
Part A: prexasertib + ralimetinib
Cohort 1: 60 milligrams (mg) prexasertib (LY2606368) given intravenously (IV) and 100 mg ralimetinib given orally.
Cohort 2: 60 mg prexasertib (LY2606368) given intravenously (IV) and 200 mg ralimetinib given orally.
干预措施: prexasertib (Drug)
Part A: prexasertib + ralimetinib
Cohort 1: 60 milligrams (mg) prexasertib (LY2606368) given intravenously (IV) and 100 mg ralimetinib given orally.
Cohort 2: 60 mg prexasertib (LY2606368) given intravenously (IV) and 200 mg ralimetinib given orally.
干预措施: ralimetinib (Drug)
Part B1: prexasertib + ralimetinib (colorectal cancer)
60 mg prexasertib (LY2696368) given IV and 200 mg ralimetinib given orally. Participants receive prexasertib IV on Days 1 and 15 and ralimetinib every 12 hours (Q12H) Days 1 and 14 of a 28 day cycle.
干预措施: prexasertib (Drug)
Part B1: prexasertib + ralimetinib (colorectal cancer)
60 mg prexasertib (LY2696368) given IV and 200 mg ralimetinib given orally. Participants receive prexasertib IV on Days 1 and 15 and ralimetinib every 12 hours (Q12H) Days 1 and 14 of a 28 day cycle.
干预措施: ralimetinib (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib
时间窗: Cycle 1 (28 Days)
次要结局
- PK: Cmax of Ralimetinib(Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles))
- PK: AUC of Ralimetinib(Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles))
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib(Cycle 1 Day 1 through Cycle 3 Day 1 (28 Day Cycles))
- PK: Area Under the Curve (AUC) of Prexasertib(Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles))
- Best Overall Response (BOR): Percentage of Participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE)(Baseline to Earliest Objective Progression or Start of New Anticancer Therapy (Estimated up to 32 Weeks))
- Disease Control Rate (DCR): Percentage of Participants who Exhibit SD, CR or PR(Baseline through Measured Progressive Disease (Estimated up to 32 Weeks))
- Duration of Response (DOR)(Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 32 Weeks))
- Progression Free Survival (PFS)(Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 32 Weeks))