ACNS1931 A Phase 3 Study of Selumetinib (NSC# 748727, IND# 77782) or Selumetinib in Combination with Vinblastine for non-NF1, non-TSC Patients with Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations
ACNS1931
What is the goal of the study?
ACNS1931 is a prospective, randomized, phase 3 study comparing selumetinib to selumetinib + vinblastine in children with progressive LGG not associated with neurofibromatosis, tuberous sclerosis, BRAFV600E mutations, or IDH1mutations. The study will begin with a brief feasibility (dose-finding) phase to establish the maximum tolerated/recommended phase 2 dose of selumetinib + vinblastine prior to initiation of the efficacy phase. The efficacy phase will compare event-free survival, tumor response, vision, and quality of life for patients treated with selumetinib versus selumetinib + vinblastine. It will also examine the impact of BRAF rearrangement on event-free survival and tumor response following treatment with both selumetinib-containing arms.
Who can participate in the study?
Please contact the study team listed below to learn more.