Duke logo

Agios Perioperative in Recurrent Glioma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find the best dose of the study drugs Ivosidenib (AG-120) and AG-881 to give to patients with recurrent low-grade glioma that has a mutated form of a protein called IDH and has continued to grow or came back even with previous treatment.

What is the Condition Being Studied?

Recurrent Low Grade Brain Cancer (Grade 2 or 3 Glioma)

Who Can Participate in the Study?

Adults who:
- Are diagnosed with Low Grade (II or III) glioma brain cancer that has continued to grow or come back even with prior treatment
- Have a positive test for IDH1 mutation
- Are able to have surgery

Age Group
Adults

What is Involved?

This study is now enrolling in the Cohort 2 part of the study.

If you choose to join this study, you will be randomized (like a flip of a coin) to get either:
- Group 1: The study drug ivosidenib (AG-120) taken by mouth twice a day starting at least 28 days prior to surgery.
- Group 2: The study drug AG-881 taken by mouth once a day starting at least 28 days prior to surgery.

-- After recovery from surgery (2 to 6 weeks) you will re-start taking the same study drug you took prior to surgery.
-- How much cancer tissue remained after surgery will determine how long treatment will continue.
- You will have regular clinic visits and imagining scans (MRI) so that the doctor can carefully track your progress.

Study Details

Full Title
A Phase 1, Multicenter, Randomized, Controlled, Open-label, Perioperative Study of AG-120 and AG-881 in Subjects with Recurrent, Non-enhancing, IDH1 Mutant, Low-grade Glioma. (AG120-881-C-001)
Principal Investigator
Protocol Number
IRB:PRO00089555
NCT:NCT03343197
Phase
Phase I
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698