NCT04587830

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

Phase 1-2 Trial of ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma Multiforme (GBM)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Polaris Group · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

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 as noted for the Phase 1 portion. Furthermore, ADI-PEG 20 or placebo treatment may continue after adjuvant TMZ if there is no progressive disease, for up to a total of 2 years of ADI-PEG 20 or placebo treatment. In addition, after 24 weeks (6 cycles) subjects may also continue adjuvant TMZ along with ADI-PEG 20 or placebo, in the absence of disease progression, as noted above, if clinically indicated in the investigator's judgement. MRI is to be performed post-surgery(biopsy), and then at 1, 3 and 6 months after completion of radiotherapy and then every 3 months for up to 24 months.

Conditions

• Glioblastoma Multiforme (GBM)

Interventions

Type	Name	Description
DRUG	ADI-PEG 20	Investigational Medicine
DRUG	Temozolomide	Radiotherapy and TMZ are standard front-line therapy for newly diagnosed GBM.
DRUG	Placebo	Investigational Medicine

Timeline

• Start date: 2020-09-14
• Primary completion: 2027-02-28
• Completion: 2027-05-30
• First posted: 2020-10-14
• Last updated: 2025-08-26

Locations

10 sites across 2 countries: South Korea, Taiwan

Regulatory

• FDA-regulated drug study