Spots Global Cancer Trial Database for A Single-Arm Phase II Exploratory Clinical Study of Pemigatinib in the Treatment of Advanced Gastric and Colorectal Cancer Patients With FGFR Alterations Who Have Failed Standard Therapy
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Trial Identification
Brief Title: A Single-Arm Phase II Exploratory Clinical Study of Pemigatinib in the Treatment of Advanced Gastric and Colorectal Cancer Patients With FGFR Alterations Who Have Failed Standard Therapy
Official Title: A Single-Arm Phase II Exploratory Clinical Study of Pemigatinib in the Treatment of Advanced Gastric and Colorectal Cancer Patients With FGFR Alterations Who Have Failed Standard Therapy
Study ID: NCT05202236
Conditions
Interventions
Study Description
Brief Summary: This study is a prospective single-arm phase II clinical study. Advanced gastric and colorectal tumor 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 9 weeks (± 7 days) after week 48. Safety will be assessed according to NCI-CTCAE 5.0.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Contact Details
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