A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

Novartis

Status and phase

Completed

Phase 2

Conditions

Recurrent Glioblastoma or Other Glioma Subtypes

Treatments

Drug: BGJ398

Study type

Interventional

Funder types

Industry

Identifiers

NCT01975701

CBGJ398X2201

Details and patient eligibility

About

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.

Full description

Patients were enrolled in two groups. Group 1 enrolled patients who are not candidates for surgery. Group 2 was planned to enroll patients who are surgical candidates. Patients from both groups were evaluated for tumor response and progression by MRI every 8 weeks until disease progression or discontinuation from study using RANO criteria.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with histologically confirmed GBM and/or other glioma subtypes at the time of diagnosis or prior relapse.
Written documentation of local or central laboratory determination of amplification or translocation to FGFR1-TACC1, FGFR3-TACC-3 fusion and/or activating mutation in FGFR1, FGFR2,or FGFR3
RANO defined tumor progression by MRI in comparison to a prior scan
Patients must have received prior external beam radiotherapy and temozolomide.

Exclusion criteria

History of another primary malignancy
Prior or current treatment with a FGFR inhibitor
Neurological symptoms related to underlying disease requiring increasing doses of corticosteroids
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.