BGJ398X2201 - A Phase 2, multicenter, open-label study of BGJ398 in patients with recurrent resectable or unresectable Glioblastoma

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Investigator: Nicholas Butowski, MD
Sponsor: Novartis Pharma AG

Location(s): United States

Description

This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to patients with recurrent Glioblastoma, whose tumors demonstrate FGFR amplification, translocation, or activating mutation.  Patients will be enrolled in two groups. Group 1 will enroll patients who are not candidates for surgery. Group 2 will enroll patients who are surgical candidates. Patients from both groups will be evaluated for tumor response and progression by MRI every 8 weeks until disease progression or discontinuation from study using RANO criteria.