A Phase 2, multicenter, open-label study of BGJ398 in patients with recurrent resectable or unresectable Glioblastoma

Phase 1

Conditions: recurrent resectable or unresectable Glioblastoma
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-002200-13-BE

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 34

Inclusion Criteria

1)Patients with histologically confirmed GBM and/or other glioma
subtypes at the time of diagnosis or prior relapse.
2) Documentation of FGFR1-TACC1, FGFR3-TACC-3 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

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<br>and/or other glioma subtypes with FGFR1-TACC1,<br>FGFR3-TACC3 fusion and/or activating mutation in FGFR1,2 or 3, based<br>on PFS6.;Secondary Objective: 1) To further assess the anti-tumor activity of BGJ398 for patients with<br>GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3<br>fusion and/or activating mutation in FGFR1,2 or 3 based on Overall<br>Response Rate (ORR)<br>2) To further assess the anti-tumor activity of BGJ398 for patients with<br>GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3<br>fusion and/or activating mutation in FGFR1,2 or 3, based on Overall<br>Survival (OS)<br>3) To characterize the safety and tolerability of BGJ398;Primary end point(s): progression free survival;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Overall response rate<br>2) Overall survival<br>3) safety and tolerability;Timepoint(s) of evaluation of this end point: 1) 8 months after LPLV<br>2) 8 months after LPLV<br>3) continuous