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

NCT05997459 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-08-18

No results posted yet for this study

Summary

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.

Conditions

  • Locally Advanced Unresectable Gastric Cancer

Interventions

DRUG

Pemigatinib

Pemigatinib,13.5mg ,QD,po, 2 weeks / 1 week;Q 3W

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-25
Primary Completion
2024-12-30
Completion
2025-03-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05997459 on ClinicalTrials.gov