NCT04258527已完成1 期
A Phase 1, Open-Label, Pharmacokinetic(PK), Pharmacodynamics(PD) and Safety Study of Pemigatinib in Patients With Advanced Malignancies With FGF/FGFR Alterations
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
- Maximum observed plasma concentration (Cmax) during the dosing interval and Cmin of Pemigatinib as monotherapy
研究概览
简要总结
This is a phase 1 study to investigate the characteristics of PK, PD and safety in subjects with advanced malignancies with FGF/FGFR alterations.
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
- •Men and women, aged 18 or older.
- •Histologically or cytologically confirmed malignancy which was considered to be surgically unresectable advanced, relapse or metastatic .
- •Radiographically measurable disease per RECIST v 1.1
- •Documentation of FGF/FGFR alteration..
- •Documented disease progression after standard therapy ,or no standard therapy available.
- •ECOG performance status of 0~
- •Life expectancy ≥12 weeks
排除标准
- •Prior receipt of a selective FGFR inhibitor.
- •History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of softy tissues ( exception: skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance).
- •Currently evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
- •Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. Topical ketoconazole will be allowed
研究组 & 干预措施
Patients with advanced malignancies with FGF/FGFR alterations
Experimental
干预措施: Pemigatinib (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) during the dosing interval and Cmin of Pemigatinib as monotherapy
时间窗: Day 1 to Day 16
Time to maximum plasma concentration (Tmax) of Pemigatinib as monotherapy
时间窗: Day 1 to Day 16
Area under the single-dose plasma concentration-time curve (AUC0-t) of Pemigatinib as monotherapy
时间窗: Day 1 to Day 16
次要结局
- Safety of pemigatinib as monotherapy as assessed by the frequency, duration, and severity of adverse events(From screening through 30-35 days after end of treatment, up to 6 months)
研究者
研究点 (1)
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