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

OVARTIS FARMA S.p.A0 个研究点目标入组 26 人开始时间: 2013年12月23日最近更新: 2020年9月15日

适应症

试验速览

暂无简介。

•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 26
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•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

发起方

OVARTIS FARMA S.p.A