A Phase 1 Study of LY3009120 in Patients With Advanced or Metastatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Maximum Tolerated Dose (MTD) of LY3009120
研究概览
简要总结
The main purpose of this study is to see how safe the investigational drug known as LY3009120 is and whether it will work to help people with advanced cancer or cancer that has spread to other parts of the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Other available therapies have failed to cure the cancer
- •The cancer that has no proven effective therapy
- •The cancer can be biopsied (depending on the tumor type and/or the dose of drug received, tumor biopsies may be required)
- •Able to swallow capsules
排除标准
- •Have active cancer in the brain or spinal cord
- •Have an active infection of any kind (fungal, viral, or bacterial)
- •Have a cancer of the blood
- •Are pregnant or breastfeeding
- •Have some types of eye problems or impairments
研究组 & 干预措施
Cohort 4 Dose Escalation
LY3009120 400 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met
干预措施: LY3009120 capsule (Drug)
Cohort 1 Dose Escalation
LY3009120 50 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
干预措施: LY3009120 capsule (Drug)
Cohort 2 Dose Escalation
LY3009120 100 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
干预措施: LY3009120 capsule (Drug)
Cohort 3 Dose Escalation
LY3009120 200 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
干预措施: LY3009120 capsule (Drug)
Cohort 5 Dose Escalation
LY3009120 500 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met
干预措施: LY3009120 capsule (Drug)
Cohort 6 Dose Escalation
LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met
干预措施: LY3009120 capsule (Drug)
Cohort A Dose Confirmation
LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
干预措施: LY3009120 capsule (Drug)
Cohort B Dose Confirmation
LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
干预措施: LY3009120 capsule (Drug)
Cohort C Dose Confirmation
LY3009120 300 mg given orally twice daily every 12 hours for a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.
干预措施: LY3009120 capsule (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of LY3009120
时间窗: Cycle 1 (28 Days)
Maximum tolerated dose for the recommended Phase 2 dose (RP2D) of LY3009120 that might be safely administered to participants with advanced and/or metastatic cancer. Dose-limiting toxicity (DLT) is defined as an adverse event (AE) during Cycle 1 (28 days) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of ALT and/or AST lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of \>5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.
次要结局
- Number of Participants With Tumor Response(Baseline through progressive disease (Up to 7.36 months))
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1(Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 hours (h) post-dose)
- Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15(Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose)
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28(Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1(Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 15(Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose)
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28(Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose)