EUCTR2013-002200-13-BE进行中（未招募）1 期
A Phase 2, multicenter, open-label study of BGJ398 in patients with recurrent resectable or unresectable Glioblastoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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