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临床试验/NCT05559775
NCT05559775招募中2 期

A Single-Arm Phase II Exploratory Clinical Study of Pemigatinib in the Treatment of Advanced Gastrointestinal Cancer (Excluding Biliary Tract Cancer) Patients With FGFR Alterations Who Have Failed Standard Therapy

Zhejiang Cancer Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年8月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
20
试验地点
1
主要终点
ORR

研究概览

简要总结

This study is a prospective single-arm phase II clinical study. Advanced Gastrointestinal cancer (excluding Biliary Tract Cancer) patients with FGFR 1-3 alterations who have failed standard therapy will be enrolled in this study once they have signed the informed consent form (ICF) and been identified as eligible in screening. The patients will receive 13.5 mg of pemigatinib once a day (QD) orally following a 2-week administration/1-week interruption regimen. They will be dosed until disease progression or intolerable toxicity. During treatment, clinical tumor imaging evaluation will be performed according to RECIST v1.1 every 6 weeks (± 7 days) and then every 12 weeks (± 7 days) after week 48. Safety will be assessed according to NCI-CTCAE 5.0.

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Pemigatinib

Experimental

Selective FGFR1-3 inhibitor

干预措施: Pemigatinib Pill (Drug)

结局指标

主要结局

ORR

时间窗: about 2 years

ORR is defined as the proportion of subjects with complete response (CR) + those with partial response (PR) according to the RECIST1.1 criteria

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ying Jieer

Chief physician

Zhejiang Cancer Hospital

研究点 (1)

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