NCT01832506已完成1 期
A Japanese Multicenter, Open Label, Phase I Trial of c-Met Inhibitor MSC2156119J Given Orally as Monotherapy to Subjects With Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Subjects Experiencing Dose Limiting Toxicity (DLT)
研究概览
简要总结
This is a Japanese multicenter, open-label, Phase 1 study to evaluate safety and efficacy of MSC2156119J in subjects with malignant solid tumor which is refractory to standard therapy or to which no effective standard therapy is applicable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject with a histologically or cytologically confirmed diagnosis of malignant solid tumor which is refractory to standard therapy or to which no effective standard therapy is applicable
- •An archived tumor tissue is available or biopsy of tumor tissues can be newly performed
- •A Japanese male or female, age greater than or equal to (>=) 20 years
- •A subject who has read the Subject Information Sheet and understood the details of this clinical trial, and is willing and able to give his/her informed consent.
- •A female of child-bearing potential must have a negative blood pregnancy test result at her screening period. A female subject of child-bearing potential must be willing to avoid pregnancy by using an adequate method of contraception Life expectancy is at least 3 months
- •Other inclusion criteria apply
排除标准
- •Known Human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B
- •Presence of liver fibrosis or liver cirrhosis that has been histologically diagnosed
- •Signs or symptoms that suggest transmissible spongiform encephalopathy
- •Received major surgery within 6 weeks before Day 1 in Cycle 1
- •Known drug abuse or alcohol abuse
- •Known hypersensitivity to any of the trial treatment ingredients
- •Hematological test abnormalities
- •Renal impairment as defined in the protocol
- •Liver dysfunction as defined in the protocol
- •History or presence of central nervous system metastasis
- •History or presence of disease or condition that may hamper compliance or absorption of the investigational medicinal product (IMP) due to difficulty in swallowing or absorption
- •Poor performance status of Eastern Cooperative Oncology Group Performance status (ECOG PS) >= 2
- •Received any anti-cancer therapy days Received extensive prior radiotherapy that irradiates more than 30 percent of bone marrow
- •Received any radiotherapy within 4 weeks before Day 1 in Cycle 1
- •Pregnancy and lactation period
- •History of receiving treatment with any c-Met signaling pathway inhibitor
- •Participation in another interventional clinical trial within the past 30 days from Day 1 in Cycle 1
- •Other significant disease that in the Investigator's opinion would exclude the subject from the trial
- •Legal incapacity or limited legal capacity
- •Other exclusion criteria apply
研究组 & 干预措施
MSC2156119J
Experimental
干预措施: MSC2156119J (Drug)
结局指标
主要结局
Number of Subjects Experiencing Dose Limiting Toxicity (DLT)
时间窗: Cycle 1 (Day 1 up to 21)
DLT: defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0, as any of following toxicities: Grade 4 neutropenia for more than 7 days; greater than or equal to (\>=) Grade 3 febrile neutropenia; Grade 4 or Grade 3 thrombocytopenia with bleeding; \>=Grade 3 nausea despite adequate treatment; \>=Grade 3 any non-hematological AE (DLT defined specifically for following cases: \>=Grade 3 liver adverse event \[AE\] requiring recovery period of more than 7 days or to Grade 1 without liver metastases or Grade 2 with liver metastases ; \>=Grade 3 lipase and/or amylase elevation with confirmation of pancreatitis. An isolated lipase and/or amylase elevation of \>=Grade 3 without clinical/radiological evidence of pancreatitis was not classified as DLT); and \>=Grade 2 any AE not otherwise defined as DLT that, due to prolonged recovery to Grade 1 (or less) or baseline status, led to delay of treatment with IMP for more than 21 days.
次要结局
- Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J(pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1)
- Time to Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J(pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1)
- Time to Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J(pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1)
- Apparent Volume of Distribution Associated To The Terminal Phase (Vz/f) of MSC2156119J(pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1)
- Apparent Terminal Half-life (t1/2) of MSC2156119J(pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1)
- Apparent Body Clearance (CL/f) of MSC2156119J(pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1)
- Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time t (AUC0-t) After Single Dose of MSC2156119J(pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1)
- Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs or TEAEs Leading To Death(Baseline Up to 30 days after last dose of study drug administration (55.1 weeks))
- Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time t (AUC0-t) After Multiple Dose of MSC2156119J(pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1)
- Number of Subjects With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score of 2 or Higher(Baseline up to 30 days after last dose of study drug administration (55.1 weeks))
- Number of Subjects With Best Overall Response (BOR)(Day 21 of Cycle 2 and each subsequent cycle up to a maximum of 51.1 weeks)
- Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J(pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1)
- Area Under the Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC[Inf]) of MSC2156119J(pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1)
- Progression-free Survival (PFS)(Day 21 of Cycle 2 and each subsequent cycle up to a maximum of 51.1 weeks)
- Number of Subjects With Clinical Benefit(Day 21 of Cycle 2 and each subsequent cycle up to a maximum of 51.1 weeks)
研究者
研究点 (1)
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