recurrent resectable or unresectable Glioblastoma
Conditions
Interventions
Product Code: BGJ398
Pharmaceutical Form: Capsule, hard
Current Sponsor code: BGJ398
Other descriptive name: BGJ398
Concentration unit:
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with histologically confirmed GBM and/or glioma subtypes at the time of diagnosis or prior relapse. 2) Documentation of FGFR1-TACC1, FGFR3-TACC3 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. Other protocol defined criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 27 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
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. Other protocol defined criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1,2,or 3, based on PFS6.; Secondary Objective: 1) To further assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1,2,or 3, based on Overall Response Rate (ORR) 2) To further assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1,2, or 3, based on Overall Survival 3) Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose interruptions, reductions and dose intensity, and evaluations of laboratory values ;Primary end point(s): progression free survival;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Overall response rate 2) Overall survival 3) safety and tolerability ; Timepoint(s) of evaluation of this end point: 1) 8 months after LVLS (last visit last subject) 2) 8 months after LVLS 3) continuous | — |
Countries
Australia, Belgium, Germany, Italy, Netherlands, Spain, Switzerland, United States
Contacts
Public ContactTrial manager
Novartis Pharma BV
Outcome results
None listed