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

ovartis Pharma Services AG0 个研究点目标入组 26 人开始时间: 2013年12月24日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•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
•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

发起方