A Phase 1 Open-Label, Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Japanese Patients With Advanced Gastric or Gastroesophageal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Clearance (CL) of FPA144
研究概览
简要总结
The main objectives of this study are:
- To determine the recommended dose (RD) of FPA144 in participants with gastric or gastroesophageal cancer (hereafter referred to as gastric cancer)
- To evaluate the safety of escalating doses of FPA144 in participants with gastric cancer
- To characterize the pharmacokinetic (PK) profile of single and multiple doses of intravenously administered FPA144 in participants with gastric cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma that is locally recurrent or metastatic and has progressed following standard treatment or is not appropriate for standard treatment
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Adequate hematological, liver and kidney function. Measurable or non-measurable disease
- •Archival tumor tissue for determination of FGFR2 status
排除标准
- •Untreated or symptomatic central nervous system (CNS) metastases
- •Clinically significant cardiac disease
- •Peripheral sensory neuropathy >/= Common Terminology Criteria for Adverse Events (CTCAE) Grade 2
- •Active infection requiring systemic treatment
- •Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or known active or chronic hepatitis B or C infection
- •Prior treatment with any selective inhibitor of the fibroblast growth factor (FGF)-FGFR pathway
- •Known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer
- •Known positivity for human epidermal growth factor receptor 2 (HER2)
- •Women who are pregnant or breastfeeding
研究组 & 干预措施
FPA144
Participants will receive escalating doses of FPA144. On completion of Cycle 1 (Cycles = 28 days in length) participants may participate in an optional Extended Treatment Period based on the Investigator's discretion, which begins on Day 1 of Cycle 2. FPA144 will be administered once every 2 weeks (Q2W) in 4-week cycles until disease progression, or until the patient meets any of the other withdrawal criteria.
干预措施: FPA144 (Drug)
结局指标
主要结局
Clearance (CL) of FPA144
时间窗: Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
Volume of Distribution of FPA144
时间窗: Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
Number of Participants who Experience Grade 3 or Grade 4 Dose-limiting Toxicities (DLTs)
时间窗: Day 1 to Day 28 of Cycle 1
DLTs are defined as specific adverse events (AEs) or clinically laboratory abnormalities that occur during the DLT observation period (Day 1 to Day 28 of Cycle 1; cycle = 28 days), that the Cohort Review Committee (CRC) assess as related to FPA144. Events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: * Grade 3: Severe or medically significant but non-immediately life threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; severe AE * Grade 4: Life-threatening consequences; urgent intervention indicated
Area Under Serum Concentration-time Curve (AUC) of FPA144
时间窗: Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
Maximum Serum Concentration (Cmax) of FPA144
时间窗: Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
Trough Serum Concentration (Ctrough) of FPA144
时间窗: Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
Terminal Half-life (t1/2) of FPA144
时间窗: Cycle 1: Pre-dose (within 4 hours prior to infusion on Day 1) and 0.5, 3, 6, 24, 72, and 168 hours after end of infusion; Subsequent cycles: Pre-dose (within 4 hours prior to infusion) and 0.5 hours after end of infusion on Day 1 and Day 15
次要结局
- Number of Participants who Experience Treatment-emergent AEs (TEAEs)(Approximately 1 year)