Purpose of this Study
Participants will be randomly assigned to receive either standard treatment or standard treatment plus the study drug vorasidenib. All participants will receive radiation therapy followed by temozolomide. After the first year, participants will continue taking either vorasidenib or a placebo until their tumor worsens or their doctor recommends stopping treatment. The medications are taken by mouth once a day.
Who Can Participate?
Eligibility
Participants may be able to join if they are age 12 or older with a grade 3 IDH-mutant astrocytoma and have tumor tissue available for testing. They must have recently had surgery or a biopsy, be planning to receive radiation therapy and chemotherapy, and be able to undergo MRI scans. Participants cannot have received prior cancer treatments for this tumor, have cancer that has spread to the spinal cord or brain lining, be pregnant, or have certain serious infections, heart conditions, or tumor bleeding.
Age Range
12-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is comparing standard treatment with standard treatment plus the study drug vorasidenib in people with this type of brain tumor. Researchers want to learn if adding vorasidenib can help shrink the tumor or keep it from growing compared with the usual treatment alone.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
A072301: Phase III Trial of Radiotherapy Followed by Adjuvant Temozolomide in Combination with the IDH Inhibitor Vorasidenib vs Placebo in IDH-Mutated Newly-Diagnosed Grade 3 Astrocytomas
Principal Investigator
Katherine
Peters
Protocol Number
PRO00120875
NCT ID
NCT07215910
Phase
III
Enrollment Status
Pending Open to Enrollment