EUCTR2020-003657-30-NL进行中（未招募）1 期
FIREFLY-1: A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients with RAF-Altered, Recurrent or Progressive Low-Grade Glioma and Advanced Solid Tumors - FIREFLY-1
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
- •- Patients must be age 6 months to 25 years, inclusive, with:
- •a) Arm 1 (Low-Grade Glioma): A relapsed or progressive low-grade glioma (LGG) with a documented known activating BRAF alteration.
- •b) Arm 2 (Low-Grade Glioma Extension): A relapsed or progressive low-grade glioma with a
- •documented known or expected to be activating BRAF mutation or RAF fusion.
- •c) Arm 3 (Advanced Solid Tumor): Locally advanced or metastatic solid tumor with a documented
- •known or expected to be activating RAF fusion.
- •- Patients must have histopathologic verification of malignancy at either original diagnosis or relapse.
- •- Must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression (Arm 1 and Arm 2).
- •- Patients must have evaluable and/or measurable disease as specified below:
- •a) Arm 1 (Low-Grade Glioma):Must have at least one measurable lesion.
- •b) Arm 2 (Low-Grade Glioma Extension): Must have evaluable and/or measurable disease
- •c) Arm 3 (Advanced Solid Tumor): Must have at least one measurable lesion
- •- Patients must have Karnofsky (those 16 years and older) or Lansky (those younger than 16 years) performance score of at least 50.
- •For the complete list of the inclusion criteria, please refer to the protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 140
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patient has symptoms of clinical progression without radiographically recurrent or radiographically progressive disease.
- •- Patient has history of any major disease, other than the primary malignancy under study, that might interfere with safe protocol participation
- •- Patient has major surgery within 14 days (2 weeks) prior to C1D1
- •- Patient has clinically significant active cardiovascular disease, or history of myocardial infarction, or deep vein thrombosis/pulmonary embolism within 6 months prior to C1D1
- •- Patient is currently enrolled in any other investigational treatment study. Participation in a concurrent observational or bio-sampling study is allowed.
- •For the complete list of the exclusion criteria, please refer to the protocol.
研究者
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