ACNS1831: 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)

Brief description of study

The purpose of the study is to compare the efficacy of two treatments. The purpose is to determine whether the efficacy of treatment with selumetinib as measured by event-free survival (EFS) is non-inferior to treatment with carboplatin/vincristine (CV) in previously untreated Neurofibromatosis type 1 (NF1)-associated low-grade glioma (LGG). Selumetinib (AZD6244/ ARRY-142886) is a potent, selective, orally-available, investigative drug, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.


Clinical Study Identifier: s19-01614
ClinicalTrials.gov Identifier: NCT03871257
Principal Investigator: Sharon L Gardner.
Other Investigator: Theodore P Nicolaides.


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