NCT03235570已完成1 期
A Phase 1, Open-Label, Dose-Escalation, Dose-Expansion, Safety and Tolerability Study of Pemigatinib in Japanese Subjects With Advanced Malignancies - (FIGHT-102)
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
- 44
- 试验地点
- 12
- 主要终点
- Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of pemigatinib in Japanese subjects with advanced malignancies.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First generation Japanese; subject was born in Japan and has not lived outside of Japan for a total of > 10 years and subject can trace maternal and paternal Japanese ancestry.
- •Part 1: Any histologically confirmed advanced solid tumor malignancy. Subjects enrolled at a lower dose level expansion cohort are required to have documented FGF/FGFR alterations and baseline and on-treatment tumor biopsy for testing of biomarkers.
- •Part 2: Any histologically confirmed advanced solid tumor malignancy with a FGF/FGFR alteration
- •Advanced or metastatic and recurrent cancer where an appropriate treatment option is not available.
- •Life expectancy > 12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status: Part 1: 0 or 1; Part 2: 0, 1, or
- •Genomic testing is mandatory for all enrolled subjects. Archival tumor specimen of at least 7 slides or willingness to undergo a pretreatment tumor biopsy to provide a tumor block or at least 7 unstained slides. Archival tumor biopsies are acceptable at baseline and should be no more than 2 years old (preferably less than 1 year old and collected since the completion of the last treatment); subjects with samples older than 2 years old and/or with sequencing report from the central laboratory require approval from the sponsor medical monitor for exemption from tumor biopsy or tumor sample requirement.
排除标准
- •Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives (whichever is longer) before first dose of study drug (6 weeks for mitomycin-C or nitrosoureas, 7 days for tyrosine kinase inhibitors).
- •Prior receipt of a selective FGFR inhibitor.
- •Laboratory and medical history parameters outside Protocol-defined range.
- •History and/or current evidence of ectopic mineralization/calcification including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcification.
- •Current evidence of corneal disorder/keratopathy including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, confirmed by ophthalmologic examination.
研究组 & 干预措施
Pemigatinib
Experimental
Part 1 is an open-label dose-escalation design based on observing each dose level for a period of 21 days. Part 2 will evaluate the recommended dose determined in Part 1.
干预措施: Pemigatinib (Drug)
结局指标
主要结局
Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)
时间窗: Baseline through 30 days after end of treatment, up to approximately 16 months.
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.
次要结局
- Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1(Baseline and Day 15 of every third treatment cycle, up to approximately 6 months)
- Pharmacodynamics of pemigatinib assessed by changes in serum phosphorus level(Baseline and protocol-defined timepoints throughout the treatment period, up to approximately 6 months)
- Observed Plasma Concentration of pemigatinib(During the first cycle, up to Day 16)
研究者
研究点 (12)
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