Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04576117 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial
NCT04576117 · ClinicalTrials.gov record · last posted 2026-07-02

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

StatusActive, Not Recruiting
PhasePhase 3
Started2021-02-16
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 1 change detected by DataLookout

2026-06-25
Primary endpoint(s) modified
WasEvent-free survival (efficacy), Maximum tolerated dose/recommended phase II dose (MTD/RP2D) of selumetinib and vinblastine combination (feasibility)
NowEvent-free survival (EFS) (efficacy), Maximum tolerated dose/recommended phase II dose (MTD/RP2D) of selumetinib and vinblastine combination (feasibility)
Trial Details
NCT Number NCT04576117
Lead Sponsor National Cancer Institute (NCI)
Conditions Recurrent Low Grade Astrocytoma, Recurrent WHO Grade 2 Glioma, Refractory Low Grade Astrocytoma, Refractory Low Grade Glioma, Refractory WHO Grade 1 Glioma
Enrollment 300 participants
Start Date 2021-02-16
Primary Completion 2026-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-02