drugset / Trial / NCT02824133

Treatment With AZD4547 for Recurrent Malignant Glioma Expressing FGFR-TACC Gene Fusion"

NCT02824133

Phase 1/2 Completed 14 enrolled Assistance Publique - Hôpitaux de Paris
NaSingle-groupOpen-labelTreatment

Summary

The investigators will look for the presence of the fusion gene in all patients operated on for glioma. This search will be limited to all gliomas that show no IDH1 mutation, the latter being sought in both routine and anomalies never co-existing. The hypothesis is that the rate of progression-free survival in grade IV gliomas and III without IDH1 mutation, with the usual chemotherapy, only 15% at 6 months (ie, 85% of patients relapse before 6 months of treatment), must be with this new treatment 35% (primary endpoint). The main objective is the evaluation of disease-free survival at 6 months.

Timeline

Start
2015-09
Primary completion
2017-09
Completion
2018-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Fexagratinib Small molecule 80 mg Oral

Indications