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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

Gastrointestinal Cancer Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05559775
Study type Interventional
Source Zhejiang Cancer Hospital
Contact Jieer Ying, Doctor
Phone 13858195803
Email jieerying@aliyun.com
Status Recruiting
Phase Phase 2
Start date August 10, 2022
Completion date August 10, 2025
View Details
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