NCT05267106

Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations (FIGHT-209)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, monotherapy study of pemigatinib in participants with recurrent glioblastoma (GBM) or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors with an activating FGFR1-3 mutation or fusion/rearrangement. This study consists of 2 cohorts, Cohorts A, and B, and will enroll approximately 82 participants into each cohort. Participants will receive pemigatinib 13.5 mg QD on a 2-week on-therapy and 1-week off-therapy schedule as long as they are receiving benefit and have not met any criteria for study withdrawal.

Conditions

• Glioblastoma
• Adult-type Diffuse Gliomas

Interventions

Type	Name	Description
DRUG	Pemigatinib	13.5mg tablet taken every morning (unless otherwise directed) for 2 weeks and then 1 week off.

Timeline

• Start date: 2022-05-20
• Primary completion: 2024-12-17
• Completion: 2024-12-17
• First posted: 2022-03-04
• Last updated: 2025-12-30
• Results posted: 2025-12-30

Locations

79 sites across 9 countries: United States, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study