recurrent resectable or unresectable Glioblastoma MedDRA version: 16.1 Level: PT Classification code 10018337 Term: Glioblastoma multiforme System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: ND
Product Code: BGJ398
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: ND
CAS Number: ND
Current Sponsor code: BGJ398
Other descriptive name: ND
Concentration unit: mg milligram
Sponsors
NOVARTIS FARMA S.p.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with histologically confirmed GBM at the time of diagnosis or prior relapse. 2) Documentation of amplification, translocation, or activating mutation to FGFR1, FGFR2, or FGFR3, or FGFR4 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 26 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
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 with an amplification, translocation, or activating mutation in FGFR1,2,3 or 4, based on PFS6 (PFS rate at 6 months as defined by RANO criteria as assessed by the investigator);Secondary Objective: 1) 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 Overall Response Rate (ORR - patients with measurable disease -as defined by RANO criteria as assessed by the investigator 2) 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 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 LPLV 2) 8 months after LPLV 3) 8 months afterLPLV | — |
Countries
Australia, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United States
Contacts
Public ContactDrug Regulatory Affairs
Novartis Farma S.p.A.
Outcome results
None listed