NCT05997459

A Single Arm, Phase II Exploratory Clinical Study of Pemitinib in Advanced Gastric Cancer With Previous Standard Therapy Failure the FGFR Variant

Status unknown Phase 2 Last updated 18 August 2023

What this trial tests

Phase 2 trial testing Pemigatinib in Locally Advanced Unresectable Gastric Cancer in 23 participants. Status unknown.

Timeline

25 August 2023

Primary endpoint
30 December 2024

30 March 2025

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	25 August 2023
Primary completion	30 December 2024
Estimated completion	30 March 2025
Sites	1 location across China

Drugs / interventions tested

• Pemigatinib (PEMIGATINIB) — full drug profile →

Conditions studied

• Locally Advanced Unresectable Gastric Cancer — all drugs for Locally Advanced Unresectable Gastric Cancer →

Sponsor

Sun Yat-sen University

Who can join

18 and older, any sex, with Locally Advanced Unresectable Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

purpose of research： fundamental purpose:

• To evaluate the effectiveness of pemitinib in patients with advanced gastric cancer who have failed standard therapy with fibroblast growth factor receptor 1-3 (FGFR1-3) variant (including but not limited to FGFR1-3 amplification, rearrangement / fusion, mutation, etc.).

Secondary purpose:

* To evaluate the safety and tolerability of pemitinib in patients with advanced gastric cancer who have previously failed standard therapy with the FGFR1-3 variant: including incidence of adverse events (AEs) and serious adverse events (SAEs) and association with therapy. Incidence of treatment-related AEs / SAEs.
* Exploring efficacy and safety in subjects with different FGFR variant types.

The end of the study:

Main end point:

• The primary endpoint of the study was the 6-month PFS rate (progression-free survival, defined as first dose to disease progression \[PD\] or death).

Secondary end point:

• Objective response rate (defined as the proportion of subjects achieving complete response (CR) or partial response (PR) by RECIST1.1 criteria).

Duration of response (DOR, defined as the time from first CR or PR to PD, is used only for subjects with an objective response).

* Disease control rate (DCR, defined as the proportion of subjects with CR + PR + stable disease stable \[SD\]).
* Overall survival (OS, defined as the time of first dose to death from any cause).
* Safety and tolerability: Grade evaluation for assessing the severity of adverse events according to NCI CTCAE (version 5.0), including:

1. Incidence, severity, and association of all AEs, TRAEs, SAEs, and the study drug;
2. Number and proportion of subjects stopping treatment due to the above adverse events;
3. Study changes in vital signs, physical examination findings, and laboratory results before, during and after treatment.
* To describe the efficacy and safety in subjects with different FGFR gene variant types.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Unveiling promising targets in gastric cancer therapy: A comprehensive review.
   Li W, Wei J, Cheng M, Liu M. · · 2024 · cited 10× · PMID 39280587 · DOI 10.1016/j.omton.2024.200857
2. FGFR as a Predictive Marker for Targeted Therapy in Gastrointestinal Malignancies: A Systematic Review.
   Seraji N, Berger I. · · 2025 · cited 2× · PMID 40205008 · DOI 10.1007/s12029-025-01214-y