A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (Brain Tumors)
Sponsor: |
I.R.I.S |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAS8970 |
U.S. Govt. ID: |
NCT04164901 |
Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
This study is being done to evaluate the safety and usefulness of the study drug, AG-881, as compared to placebo (a medically inactive substance) in residual or recurrent non-enhancing Grade 2 glioma (a type of brain cancer) that has a mutation in the IDH1 or IDH2 metabolic enzyme (a substance produced by the body to assist in breaking down chemicals). Subjects will be randomly assigned to receive either AG-881 or placebo in this study and will have a 50/50 chance of being assigned to either of the study groups. The subjects, study doctors, staff, and the Sponsor of the study will not know which study drug subjects are assigned to.
This study is closed
Investigator
Andrew Lassman, MD
Are you/your child at least 12 years old? |
Yes |
No |
Do you/your child have Grade 2 oligodendroglioma or astrocytoma? |
Yes |
No |
Have you/your child had at least 1 prior surgery for glioma? |
Yes |
No |