NCT04256980已完成2 期
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement Who Failed at Least One Previous Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Objective response rate per RECIST 1.1
研究概览
简要总结
This is a phase 2 study to investigate the efficacy and safety of Pemigatinib in treating patients with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 rearrangement who have failed at least 1 previous therapy
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 cholangiocarcinoma which was considered to be advanced/metastatic or surgically unresectable by the investigator through image examination.
- •Radiographically measurable disease per RECIST v 1.1
- •Documentation of FGFR2 rearrangement.
- •Documented disease progression after at least 1 line of prior systemic therapy.
- •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
Pemigatinib in patients with advanced/metastatic or surgically
Experimental
Patients with advanced/metastatic or surgically unresectable cholangiocarcinoma
干预措施: Pemigatinib (Drug)
结局指标
主要结局
Objective response rate per RECIST 1.1
时间窗: Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 24 months
次要结局
- PFS（PFS= first dose to progressive disease or death）(Time from first treatment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months)
- DOR（DOR= time from the date of CR or PR until PD）(Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 24 months)
- DCR（DCR=CR + PR + stable disease）(Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 24 months)
- OS（OS= first dose to death of any cause）(Time from first treatment to the date of death from any cause, up to 24 months)
研究者
研究点 (1)
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