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)
Study of AG-881 in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
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
Additional Study Information: 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.
Investigator
Andrew Lassman, MD
Do You Qualify?
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
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162