A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

• Status: Completed
• Trial end date: 2018-10-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Infigratinib

Criteria

Inclusion criteria:

1. Patients with histologically confirmed GBM and/or other glioma subtypes at the time of diagnosis or prior relapse.

2. 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

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.