A Phase III Study of AG-881 versus Placebo in People with IDH-Mutated Low-Grade Glioma after Surgery

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Full Title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation

Purpose

The usual approach to low-grade glioma persisting after surgery is to monitor it and not give additional treatment unless the patient experiences symptoms. This study is comparing the investigational drug AG-881 with a placebo (inactive drug) in patients with persistent low-grade gliomas that contain abnormal IDH1 or IDH2 proteins.

Normally, these proteins provide the body’s cells with energy from nutrients. When they are mutated (altered), they produce too much 2-HG: a substance that is found at low levels in normal cells, but at high levels can cause cellular changes that lead to glioma.

AG-881 is designed to block abnormal IDH1 and IDH2 proteins in cancer cells, which may prevent cancer from growing or spreading. Patients in this study will be randomly assigned to receive AG-881 or a placebo. AG-881 is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have grade 2 oligodendroglioma or astrocytoma that persists or came back after surgery and contains mutated IDH1 or IDH2.
  • Patients may not have high-risk features such as brainstem involvement, neurocognitive symptoms (such as headaches, inability to focus, or memory loss), or uncontrolled seizures.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 12 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Ingo Mellinghoff at 646-888-2766 or the Brain Tumor Hotline at 866-886-9807.

Protocol

19-463

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators