Clinical Trials
Sponsor:
Sponsor Study ID:
Study Title:
A Phase 3 Randomized Study of Selumetinib (IND # 77782) Versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low Grade Glioma (LGG)
NCT Number:
NCT03871257
Phase:
III
Protocol Type:
Treatment
Age Group:
Children
Disease Sites:
Brain and Nervous System
Study Objectives:
This phase III trial studies if selumetinib works just as well as the standard treatment with carboplatine/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 tumor cells need for their growth. This results in killing tumor cells. Drugs used in chemotherapy, 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.
Study Documents
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