A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

Status: Recruiting
Phase: Phase 2
Diagnosis: Brain/Neuro Cancer: Recurrent Glioblastoma
NCT ID: NCT01975701 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-572


This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to adult patients with histologically confirmed GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Patrick Wen, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Andrew Chi, MD, PhD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Lisa Doherty, ldoherty1@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion criteria: 1. Patients with histologically confirmed GBM at the time of diagnosis or prior relapse. 2. Documentation of amplification, translocation, or activating mutation to FGFR1, FGFR2, or FGFR3, or FGFR4 3. RANO defined tumor progression by MRI in comparison to a prior scan 4. Patients must have received prior external beam radiotherapy and temozolomide. Exclusion criteria: 1. History of another primary malignancy 2. Prior or current treatment with a FGFR inhibitor 3. Neurological symptoms related to underlying disease requiring increasing doses of corticosteroids 4. Patients must not be taking Enzyme Inducing Anti-Epileptic Drug (EIAED). If previously on an EIAED, the patient must be off of it for at least two weeks prior to study treatment.
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