A Multi-center, Phase Ib Study of MEK (Mitogen Activated Protein Kinase/ERK Kinase) Inhibitor BAY86-9766 Plus Gemcitabine in Asian Patients With Advanced or Refractory Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 23
- 主要终点
- Plasma concentration of M17 and M11
研究概览
简要总结
This is an open-label, uncontrolled, Phase Ib study designed to evaluate the safety, tolerability, and pharmacokinetics of BAY86-9766 when given as a single agent and in combination with gemcitabine in Asian patients with advanced or refractory solid tumors.Blood samples for PK (pharmacokinetics) analyses will be collected after a single dose of BAY86-9766, multiple doses of BAY86-9766, and combination treatment of gemcitabine and BAY86-9766.
Safety evaluation will include adverse events assessment, vital signs, laboratory tests, 12-lead ECG ECG (electrocardiography), cardiac function test, and ophthalmologic examination at various time points during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Male or female patients >/= 18 years of age, with histologically or cytologically documented advanced or refractory solid tumors not amenable to standard therapy
- •Patients must have at least one measurable or evaluable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- •Patients must have a life expectancy of at least 12 weeks, and an Eastern Cooperative Oncology Group Performance Status (ECOG PS) </=1.
排除标准
- •History of cardiac disease
- •Active clinically serious infections > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
- •Known human immunodeficiency virus (HIV) infection
- •Uncontrolled seizure disorder
- •Undergoing renal dialysis
- •Known bleeding diathesis
- •History of organ allograft
- •Pregnant or breast feeding women
研究组 & 干预措施
Refametinib (BAY86-9766)+ Gemcitabine
Single dose of BAY86-9766 on Cycle 1 Day -17; twice daily dosing every day starting on day -14, start dose 50mg bid ( 30mg or 20mg are possible based on adverse events need) in addition with Gemcitabine intravenous on day 1,8 and 15 1000mg/m2
干预措施: Refametinib (BAY86-9766) (Drug)
Refametinib (BAY86-9766)+ Gemcitabine
Single dose of BAY86-9766 on Cycle 1 Day -17; twice daily dosing every day starting on day -14, start dose 50mg bid ( 30mg or 20mg are possible based on adverse events need) in addition with Gemcitabine intravenous on day 1,8 and 15 1000mg/m2
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Plasma concentration of M17 and M11
时间窗: Multiple time points up to 6 day
Plasma concentration of BAY86-9766
时间窗: Multiple time points up to 6 day
Plasma concentration of Gemcitabine
时间窗: Multiple time points up to 6 day
Plasma concentration of dFdU
时间窗: Multiple time points up to 6 day
Number of adverse events, or abnormal parameters as a measure of safety and tolerability
时间窗: Up to 1 year
Parameters are laboratory parameters, vital signs, ECG parameters, cardiac function, and parameters of ophthalmologic examinations
次要结局
- Efficacy of BAY86-9766 shown by a discrete scale(Up to 1 year)