Pemigatinib for FGF/FGFR Alterations Advanced Pan Solid Tumors

Solid Tumor Clinical Trial

Official title: Safety and Efficacy of Pemigatinib in the Treatment of Advanced Pan Solid Tumors With FGF/FGFR Alterations: An Open, Single-arm, Prospective Phase II Trial

Status Recruiting

Clinical Trial Summary

The purpose of this clinical trial is to demonstrate safety and efficacy of Pemigatinib in the treatment of advanced pan solid tumor patients with FGF/FGFR alterations.

Clinical Trial Description

This study is a prospective, single arm, phase II clinical study. Patients with advanced solid tumors who had previously failed standard treatment and had FGFR1-3 alterations were selected and included in this study after signing the informed consent form and meeting the inclusion criteria. The patient will receive oral treatment with pemitinib (13.5 mg QD, administered for 2 weeks/discontinued for 1 week). Before assessment for eligibility, patients were prescreened centrally for FGF/FGFR status using massively parallel DNA sequencing.Patients who already had an FGF/FGFR status report based on local assessment (Clinical Laboratory Improvement Amendments [CLIA]-certifed) or an existing MTB approved report were also included. The subjects will continue treatment until disease progression or intolerable toxicity occurs. During the treatment process, clinical tumor imaging evaluation was conducted according to RECIST v1.1, every 6 weeks (± 7 days), and every 9 weeks (± 7 days) after 48 weeks. Use NCI-CTCAE 5.0 for safety assessment. ;

Related Conditions & MeSH terms

• Solid Tumor

• NCT number: NCT06022289
• Study type: Interventional
• Source: Tianjin Medical University Second Hospital
• Contact: HaiTao Wang, Ph.D
• Phone: +86-022-88326385
• Email: peterrock2000@126.com
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2023
• Completion date: May 31, 2025