Study with BGJ398 in recurrent glioblastoma patients
- Conditions
- recurrent resectable or unresectable GlioblastomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-002200-13-NL
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 26
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;<br> 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)<br> 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<br> 3) Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose<br> interruptions, reductions and dose intensity, and evaluations of laboratory values<br> ;Primary end point(s): progression free survival;Timepoint(s) of evaluation of this end point: 6 months
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): 1) Overall response rate<br> 2) Overall survival<br> 3) safety and tolerability<br> ;<br> Timepoint(s) of evaluation of this end point: 1) 8 months after LVLS (last visit last subject)<br> 2) 8 months after LVLS<br> 3) continuous<br>