A Phase 2, multicenter, open-label study of BGJ398 in patients with recurrent resectable or unresectable Glioblastoma
- Conditions
- Malignant brain tumorPrimary brain tumor grade 2-410027656
- Registration Number
- NL-OMON44518
- Lead Sponsor
- ovartis Pharma B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
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.
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint will be the progression-free survival rate at 6 month<br /><br>(PFS6 rate) based on patients pooled from Group 1 and Group 2. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary efficacy endpoints will be the ORR of patients from Group 1 and<br /><br>Group 2 with radiologically assessable enhancing disease using RANO criteria<br /><br>and OS.<br /><br><br /><br>The secondary safety endpoints will be: type, frequency, and severity of AEs<br /><br>and SAEs<br /><br>The secondary tolerability endpoints will be: dose interruptions, reductions<br /><br>and dose intensity, and evaluations of laboratory values</p><br>