NCT01179295已完成1 期
Phase 1 Study of Single Agent BAY86-9766 in Japanese Patients With Advanced or Refractory 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
- 发起方
- Bayer
- 入组人数
- 12
- 主要终点
- Safety evaluation due to results of physical examinations, vital signs, AEs, abnormal laboratory tests and 12-lead ECG, cardiac function test and ophthalmological examination.
研究概览
简要总结
This is an uncontrolled, open-label, non-randomized phase I / pharmacokinetic study of oral BAY86-9766 to investigate the safety, tolerability, pharmacokinetics, and efficacy profiles in Japanese patients with advanced solid tumors
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
- •Japanese patients, who are at least 18 years of age at the first screening examination/ visit, with advanced or refractory solid tumors not amenable to standard therapy.
- •Histological or cytological documentation of non-hematologic, malignant solid tumor, excluding primary brain or spinal tumors, with no current involvement in the central nervous system (CNS)
- •At least one measurable lesion or evaluable disease according to response evaluation criteria in solid tumors (RECIST) version 1.1
- •Eastern cooperative oncology group performance status (ECOG-PS) of 0 or 1
- •Life expectancy of at least 12 weeks
排除标准
- •Use of any anti-cancer therapy including chemotherapy, investigational agents or devices and immunotherapy within 4 weeks of the first dose of study medication
- •Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
- •Known human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C
- •Inadequate bone marrow, liver and renal function
- •Inability to swallow oral medications or any condition that could affect the absorption of orally administered drugs
- •Concomitant treatment with cytochrome P450 isoenzymes CYP3A4 inhibitors/inducers, and CYP2C19 inhibitors/ inducers
研究组 & 干预措施
Arm 1
Experimental
干预措施: BAY86-9766 (Drug)
Arm 2
Experimental
干预措施: BAY86-9766 (Drug)
Arm 3
Experimental
干预措施: BAY86-9766 (Drug)
Arm 4
Experimental
干预措施: BAY86-9766 (Drug)
结局指标
主要结局
Safety evaluation due to results of physical examinations, vital signs, AEs, abnormal laboratory tests and 12-lead ECG, cardiac function test and ophthalmological examination.
时间窗: At the end of 30-day follow up after discontinuation of study drug administration
Calculation of pharmacokinetic parameters of BAY86-9766 and its metabolite (M17).
时间窗: Cycle 1 Day 22 and Day 23 for Cohorts 1 & 2 and Cohorts 3 & 4, respectively.
次要结局
- Response rate(On average 3 months)
- Disease control rate(On average 3 months)
研究者
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