NCT06022289

Pemigatinib for FGF/FGFR Alterations Advanced Pan Solid Tumors

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Solid Tumor
• FGF Receptor Gene Mutation
• FGF Amplification
• FGF Receptor Gene Family Rearrangement
• FGF Receptor Gene Translocation

Interventions

Type	Name	Description
DRUG	Pemigatinib	Pemigatinib will be treated according to the treatment plan of 2 weeks of administration/1 week of discontinuation, with oral administration of 1 capsule, 13.5mg, QD, and a cycle of 21 days. Meanwhile, the molecular testing results of the patient are analyzed and interpreted by the MTB team, and appropriate combination therapy(Pemigatinib+) strategies are proposed based on the patient's previous treatment history, physical condition, drug accessibility, and economic status.

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-05-01
• Completion: 2025-05-31
• First posted: 2023-09-01
• Last updated: 2023-09-01

Locations

1 site across 1 country: China