Phase 2
N=26
A Phase 2 Study of BGJ398 in Patients With Recurrent GBM
Recurrent Glioblastoma or Other Glioma Subtypes
Bottom Line
View on ClinicalTrials.gov: NCT01975701 ↗Enrolled (actual)
26
Serious AEs
34.6%
Results posted
Dec 2019
Primary outcome: Primary: Progression Free Survival — 1.7 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BGJ398 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
1.7 | — |
| SECONDARY Overall Response Rate |
2; 7; 13; 3; 1 | — |
| SECONDARY Overall Survival |
6.74 | — |
| SECONDARY Safety and Tolerability |
13; 4 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01975701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.