A Phase 1 Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX7486 as a Single Agent in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- Safety of PLX7486 as single agent as measured by adverse events and serious adverse events.
研究概览
简要总结
The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of PLX7486.
详细描述
Part 1. Open-label, sequential PLX7486 TsOH single-agent dose escalation in approximately 60 patients with solid tumors.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PLX7486-TsOH, Dose escalation and RP2D
Part 1: Open-label, sequential PLX7486-TsOH single-agent dose escalation in approximately 60 patients with solid tumors.
干预措施: PLX7486 TsOH (Drug)
结局指标
主要结局
Safety of PLX7486 as single agent as measured by adverse events and serious adverse events.
时间窗: 1 year
Area under the plasma concentration-time curve [AUC0-t, AUC0-inf]
时间窗: 1 year
Area under the plasma concentration-time curve \[AUC0-t, AUC0-inf\] will be used to assess the pharmacokinetic profile of PLX7486.
Peak concentration (Cmax)
时间窗: 1 year
Peak concentration (Cmax) will be used to assess the pharmacokinetic profile of PLX7486.
Time to peak concentration (Tmax)
时间窗: 1 year
Time to peak concentration (Tmax) will be used to assess the pharmacokinetic profile of PLX7486.
Half life (t1/2)
时间窗: 1 year
Half life (t1/2) will be used to assess the pharmacokinetic profile of PLX7486.
Terminal elimination rate constant (Kel)
时间窗: 1 year
Terminal elimination rate constant (Kel) will be used to assess the pharmacokinetic profile of PLX7486.
次要结局
- Duration of response (DOR)(1 year)
- Progression-Free Survival (PFS)(6 month)
- Overall Response Rate (ORR)(1year)
- Overall Survival (OS)(1 year)