drugset / Trial / NCT04576117

A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma

NCT04576117

Phase 3 Active not recruiting 300 enrolled National Cancer Institute (NCI)
RandomizedSequentialOpen-labelTreatment

Summary

This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.

Timeline

Start
2021-02-16
Primary completion
2026-12-30
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Selumetinib Small molecule Oral
Subject Vinblastine Small molecule Intravenous