U.S., Feb. 6 -- ClinicalTrials.gov registry received information related to the study (NCT06809322) titled 'Vorasidenib Maintenance for IDH Mutant Astrocytoma' on Jan. 22.
Brief Summary: The main goal of VIGOR is to demonstrate that vorasidenib maintenance therapy improves locally assessed progression-free survival (PFS) from enrolment compared to placebo in patients with IDH-mutant, CNS5 WHO Grade 2 or 3 astrocytoma following the completion of first-line chemoradiotherapy.
The primary endpoint is Progression-free survival (PFS), as assessed locally from the date of enrolment using the RANO 2.0 criteria.
In this a comparative, randomized (1:1), triple blinded, multicentre phase III superiority trial with one stopping rule for efficacy an...