Full TitleA 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
The purpose of this study is to find the best dose of two different drugs to give to patients with recurrent low-grade glioma that contains a mutated form of a protein called IDH and has continued to grow or came back despite previous treatment. The drugs are called ivosidenib (AG-120) and AG-881.
There are two types of IDH, called IDH1 and IDH2. Abnormal IDH1 and IDH2 cause too much of a substance called 2-HG to be produced, which may make some cancers grow. Ivosidenib blocks an abnormal form of IDH1, and AG-881 blocks mutated forms of both the IDH1 and IDH2 proteins. It is thought that by stopping the function of the IDH proteins and lowering the levels of 2-HG in tumor cells, the treatment may help slow or stop the cancer cells from growing. Both drugs are taken orally (by mouth).
Patients in this study will be randomly assigned to receive one of two doses of ivosidenib, one of two doses of AG-881, or neither drug before glioma surgery. Researchers will compare patients in the various groups to determine the best dose of each drug and to assess the effect of these treatments on the function of the mutant IDH1 protein in their tumors. Patients who do not receive either drug before surgery may have the opportunity to receive one of them after surgery.
Ivosidenib is approved for treating leukemia; its use in this study is considered investigational. AG-881 is investigational.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have recurrent low-grade glioma that continued to grow or came back despite prior treatment.
- Patients’ tumors must contain an IDH1 mutation.
- Patients must be candidates for surgery.
- Patients should recover from the serious side effects of previous treatments before entering the study.
- Prior treatment with an IDH inhibitor or bevacizumab is not permitted.
- This study is for patients age 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Ingo Mellinghoff at 646-888-3036.