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
- Conditions
- brain tumormalignant glioma10029211
- Registration Number
- NL-OMON53920
- Lead Sponsor
- Day One Biopharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
- Less than 25 years of age with a low-grade glioma harboring a documented
known activating RAF alteration
- Histopathologic diagnosis of glioma or glioneuronal tumor
- At least one measurable lesion as defined by Response Assessment in Pediatric
Neuro-Oncology (RANO) criteria
- Meet indication for first-line systemic therapy
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to compare the objective response rate (ORR) assessed<br /><br>per Response Assessment in Neuro Oncology for low-grade gliomas (RANO-LGG)<br /><br>criteria by Independent Review Committee (IRC) of tovorafenib monotherapy<br /><br>versus standard of care (SoC) chemotherapy in patients with pediatric low-grade<br /><br>glioma harboring an activating rapidly accelerated fibrosarcoma gene (RAF)<br /><br>alteration requiring first line systemic therapy.</p><br>
- Secondary Outcome Measures
Name Time Method