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

NCT04587830 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-26

No results posted yet for this study

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

Conditions

  • Glioblastoma Multiforme (GBM)

Interventions

DRUG

ADI-PEG 20

Investigational Medicine

DRUG

Temozolomide

Radiotherapy and TMZ are standard front-line therapy for newly diagnosed GBM.

DRUG

Placebo

Investigational Medicine

Sponsors & Collaborators

  • Polaris Group

    lead INDUSTRY

Principal Investigators

  • Kuo-Chen Wei, M.D. · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2027-02-28
Completion
2027-05-30
FDA Drug
Yes

Countries

  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04587830 on ClinicalTrials.gov