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

NCT05997459 | Unknown Phase 2 DMC

• 1 other identifier: SL-B2023-124-02
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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:
• Incidence, severity, and association of all AEs, TRAEs, SAEs, and the study drug;
• Number and proportion of subjects stopping treatment due to the above adverse events;
• 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

Outcome Measures

Primary Outcomes (1)

• PFS

  to evaluate the efficacy of pemitinib in patients with advanced gastric cancer who have previously failed standard therapy with FGFR1-3 variants

  6-month PFS

Study Arms (1)

experimental group

EXPERIMENTAL

Drug: Pemigatinib

Interventions

Pemigatinib DRUG

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

experimental group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Main selection criteria:
• Written informed consent was signed prior to the implementation of any trial-related process;
• Age: 18 years old;
• Advanced gastric cancer was confirmed histologically or cytologically;
• At least one measurable lesion as per version RECIST v1.1;
• Histology confirmed the presence of the FGFR1-3 variant, including but not limited to amplification, mutation, fusion / rearrangement;
• Patients who are tested negative for HER 2 by immunohistochemistry (IHC), or by immunohistochemistry (ICH) and in situ hybridization (ISH);
• Progressive disease after standard treatment;
• No previous small molecule multitarget inhibitors containing FGFR pathway (including but not limited to allotinib, lemavatinib, sorafenib, apatinib, etc.);
• The ECOG physical fitness status is 0-1;
• Expected survival time of\> 3 months;

You may not qualify if:

• \- Written informed consent was signed prior to the implementation of any trial-related process;
• Age: 18 years old;
• Advanced gastric cancer was confirmed histologically or cytologically;
• At least one measurable lesion as per version RECIST v1.1;
• Histology confirmed the presence of the FGFR1-3 variant, including but not limited to amplification, mutation, fusion / rearrangement;
• Patients who are tested negative for HER 2 by immunohistochemistry (IHC), or by immunohistochemistry (ICH) and in situ hybridization (ISH);
• Progressive disease after standard treatment;
• No previous small molecule multitarget inhibitors containing FGFR pathway (including but not limited to allotinib, lemavatinib, sorafenib, apatinib, etc.);
• The ECOG physical fitness status is 0-1;
• Expected survival time of\> 3 months;
• For icient organ function for the following laboratory indicators:
• In the absence of granulocyte colony-stimulating factor for the last 14 days (ANC)≥1.5x109/L；
• In the last 14 days without blood transfusion, platelets 100109/L；
• Hemoglobin\> 9 g/dL without blood transfusion or erythropoietin in the last 14 days;
• Total bilirubin 1.5 upper limit of normal (ULN); or total bilirubin\> ULN but direct bilirubin ULN;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer center of SunYat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Interventions

pemigatinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 18, 2023
• Study Start: August 25, 2023
• Primary Completion: December 30, 2024
• Study Completion: March 30, 2025
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)