Agios-INDIGO (AG881-C-004) Recurrent Gr.2 Glioma (Age 12 and Up) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about the safety and usefulness of the study drug (AG88) in people with residual or recurrent Grade 2 glioma that have an IDH1 or IDH2 mutation.

What is the Condition Being Studied?

Brain Tumor (Grade II Glioma)

Who Can Participate in the Study?

Children, 12+ and Adults who have:
-Recurrent or residual Grade II oligodendroglioma OR an Astrocytoma brain tumor
-IDH1 or IDH2 mutation
-Have had surgery at least 1 time, 1-5 years ago
-Not had anticancer therapy before
-No major heart disease in last 6 months
-No immediate need for Radiation or Chemotherapy

Age Group
Adults, Children

What is Involved?

If you choose to join this study, you will:
-Be randomized (like flipping a coin) to Group 1 or Group 2
--Group 1 will get the study drug (AG881)
--Group 2 will get a placebo (harmless pill that does not treat anything)
*The randomization is double blinded, which means that the patients, their doctors and the study team will not know which group you will be in.

BOTH Groups will:
-Take the pill assigned to them for a 28 day cycle for as long as the pill is helpful
-Have an MRI scan of your brain every 8 weeks
-Have a clinic visit of days 1 and 15 of your cycle for the first 2 cycles
---After the first 2 cycles you will only come to the clinic on the first day of your cycle

*If a person taking the placebo has growth of their tumor while in the study, they may have the option to be given the active AG881 drug.

Study Details

Full Title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of AG-881 in Subjects with Residual/Recurrent Grade 2 Glioma with an IDH1 or IDH2 Mutation (Agios-INDIGO AG881-C-004)
Principal Investigator
Protocol Number
IRB: PRO00103951
NCT: NCT04164901
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698