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.
Completed
Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| BGJ398 | BGJ398X |
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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| BGJ398X | Experimental | To estimate anti-tumor efficacy of BGJ398 |
|
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Progression Free Survival |
| Time Frame: | 6 months |
| Safety Issue: | |
| Description: | To assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes that harbor FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3 based on PFS6 (PFS rate at 6 months as defined by RANO criteria as assessed by the investigator) |
| Measure: | Overall Response Rate |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: | To further assess the anti-tumor activity of BGJ398 for patients with GBM with an amplification, translocation, or activating mutation in FGFR1,2,3 or 4, based on Objective Response Rate (ORR - patients with measurable disease - as defined by RANO criteria as assessed by the investigator |
| Measure: | Overall Survival |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: | To further assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes that harbor FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 and 3 based on Overall Survival |
| Measure: | Safety and Tolerability |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: | Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose interruptions, reductions and dose intensity, and evaluations of laboratory values |
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Novartis Pharmaceuticals |
December 4, 2019
