drugset
drugset / Trial / NCT04587830

ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme

NCT04587830 ↗

Phase 2 Active not recruiting 100 enrolled Polaris Group
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A randomized, double-blind, placebo-controlled study. Weekly ADI-PEG 20 (36 mg/m2) or placebo will be combined with Stupp Protocol (Stupp 2005) radiotherapy and TMZ

Timeline

Start
2020-09-14
Primary completion
2027-02-28
Completion
2027-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegargiminase Protein / enzyme biologic 36 mg/m2 Intramuscular
Background Temozolomide Small molecule 150 mg/m2 Oral
Background Temozolomide Small molecule 200 mg/m2 Oral

Indications

glioblastoma