A Phase 2, multicenter, open-label study of BGJ398 in patients with recurrent resectable or unresectable Glioblastoma
- Conditions
- recurrent resectable or unresectable GlioblastomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-002200-13-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 26
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 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
- Secondary Outcome Measures
Name Time Method