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

Phase 1

Active, not recruiting

• 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

Study Timeline

• Study Start: 2014-01-16
• Last Update Posted: 2018-10-22

Recruitment & Eligibility

• Status: Not 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