A Phase 2, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of the Oral Pan-RAF Inhibitor DAY101 in Pediatric Patients with BRAF-Altered, Recurrent or Progressive Low-Grade Glioma - FIREFLY-1

DOT Therapeutics-1 Inc. (Day One)0 个研究点目标入组 60 人开始时间: 2020年10月1日最近更新: 2020年12月7日

适应症

试验速览

暂无简介。

•- Age 6 months to 25 years with a relapsed or progressive LGG with a documented known activating BRAF alteration.
•- Confirmation of histopathologic diagnosis of LGG from either original diagnosis or relapse
•- Must have received at least 1 line of systemic therapy prior and have documented evidence of radiographic progression
•- Must have at least 1 measurable lesion
•- 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: 60
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 5
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Patient has symptoms of clinical progression without radiographically recurrent or radiographically progressive disease.
•- History of any major disease, other than the diagnosis of LGG, that might interfere with safe protocol participation
•- Major surgery within 14 days (2 weeks) prior to C1D1
•- Clinically significant active cardiovascular disease, or history of myocardial infarction, or deep vein thrombosis/pulmonary embolism within 6 months prior to C1D1
•- Current enrollment 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.

发起方

DOT Therapeutics-1 Inc. (Day One)