AVAglio

Phase 3

• Conditions: Glioblastoma

• Registration Number: jRCT2080220804
• Lead Sponsor: Chugai Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 920

Inclusion Criteria

-Adult patients, >=18 years of age;
-Newly diagnosed glioblastoma;
-WHO performance status <=2;
-Stable or decreasing corticosteroid dose within 5 days prior to randomization.

Exclusion Criteria

-Evidence of recent hemorrhage or postoperative MRI of brain;
-Any prior chemotherapy or immunotherapy for glioblastomas and low grade astrocytomas;
-Any prior radiotherapy to brain;
-Clinically significant cardiovascular disease;
-History of >=grade 2 hemoptysis within 1 month prior to randomization;
-Previous centralized screening for MGMT status for enrollment into a clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Randomized, double blind, placebo controlled, multicenter Phase III trial

Primary Outcome Measures

Name	Time	Method
-		Overall survival, Progression free survival