NCT03871257 · ClinicalTrials.gov record · last posted 2026-08-13
A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma
StatusActive, Not Recruiting
PhasePhase 3
Started2020-01-15
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
This phase III trial studies if selumetinib works just as well as the standard treatment with carboplatin/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by blocking some enzymes that low-grade glioma tumor cells need for their growth. This results in killing tumor cells. Chemotherapy drugs, such as carboplatin and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether selumetinib works better in treating patients with NF1-associated low-grade glioma compared to standard therapy with carboplatin and vincristine.
Amendment record
558 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 558 times since 2019-03-11; most recent amendment 2026-06-19. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
See every version on ClinicalTrials.gov ↗
2025-06-28
Status change Recruiting→Active, Not Recruitingv482
2019-11-22
Status change Not Yet Recruiting→Recruitingv9
| NCT Number |
NCT03871257 |
| Lead Sponsor |
National Cancer Institute (NCI)
|
| Conditions |
Low Grade Glioma, Neurofibromatosis Type 1, Visual Pathway Glioma |
| Enrollment |
165 participants |
| Start Date |
2020-01-15 |
| Primary Completion |
2027-12-31 (estimated) |
| Study Completion |
2027-12-31 (estimated) |
| Updated on ClinicalTrials.gov |
2026-08-13 |