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Trial intelligence / Profile preview
AZD4547 in Relapsed/Refractory Glioma with FGFR Fusion
NCT02824133Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2015
- Primary completion
- Sep 2017
- Countries
- 1
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Modality
- Small Molecules
- Drugs
- fexagratinib
- Conditions
- glioma
01
Overview
Phase 2, open-label, single-arm trial of fexagratinib in glioma, sponsored by Assistance publique - Hôpitaux de Paris. Primary endpoint: Progression-Free Survival at 6 months. Started Sep 2015; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
AZD4547
AZD4547 80mg bd continuous
03
Who it enrols
Adult patients with recurrent IDH wild-type glioma expressing FGFR3-TACC3 or FGFR1-TACC1 fusion gene, with adequate organ function and no significant cardiac or ophthalmological conditions.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Overall Response Rate
Duration of Progression-Free Survival
Overall Survival
Safety of AZD4547
Maximum Plasma Concentration
Area Under the Curve
Residual Plasma Concentration
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