Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

The patients will receive 13.5 mg (1 pill/time) of pemigatinib once a day (QD) orally following a 2-week administration/1-week interruption regimen, with 21 days as a cycle. They should take pemigatinib at regular times of the day to avoid the effects of inconsistent timing on plasma concentrations.

pemigatinib

Tao Zhang, Doctor

Tao Zhang, MD

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.

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

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

Wuhan Union Hospital, China

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT05202236	Gastric and Col...	pemigatinib	18 Years -	Wuhan Union Hospital, China
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	NCT05202236	Gastric and Col...	pemigatinib	18 Years -	Wuhan Union Hospital, China

Spots Global Cancer Trial Database for gastric and colorectal cancer