EUCTR2022-001363-27-DK招募中1 期
OGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients with Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy - LOGGIC/FIREFLY-2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Less than 25 years of age with LGG with known activating RAF alteration
- •- Histopathologic diagnosis of glioma or glioneuronal tumor
- •- At least one measurable lesion as defined by RANO criteria
- •- Meet indication for first-line systemic therapy
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 400
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patient has any of the following tumor-histological findings:
- •a) Schwannoma
- •b) Subependymal giant cell astrocytoma (Tuberous Sclerosis)
- •c) Diffuse intrinsic pontine glioma, even if histologically diagnosed as WHO Grade I-II
- •- Patient’s tumor has additional pathogenic molecular alterations
- •- Known or suspected diagnosis of neurofibromatosis Type 1 or 2 (NF-1/NF-2)
- •- Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/IV targeted therapy) including radiation.
研究者
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