A Phase I Study of Oral AG-120 in Patients with Advanced Solid Tumors, Including Glioma, with an IDH1 Mutation

Protocol
14-068
Full Title
A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects with Advanced Solid Tumors, Including Glioma, with an IDH1 Mutation
Phase
I
Disease Status
Relapsed/Refractory
Purpose

The purpose of this study is to find the highest dose of an investigational drug called AG-120 that can be given safely in patients with advanced solid tumors that have continued to grow or have returned despite prior radiation therapy and/or chemotherapy, or for which there is no standard therapy. AG-120 is taken orally (by mouth).

AG-120 blocks an abnormal form of a protein called IDH1, which is involved in cancer cell metabolism. Abnormal IDH1 causes too much of a substance called 2-HG to be produced. Scientists believe that too much 2-HG fuels cancer growth. Patients in this study must have cancers that contain a mutated form of the IDH1 gene.

Eligibility

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

  • Patients must have an advanced malignant solid tumor, such as glioma, which has continued to grow or has come back despite prior radiation therapy and/or chemotherapy, or for which no standard therapy exists.
  • Patients’ tumors must contain an abnormal form of the IDH1 gene. Doctors will test patients’ tumors for this mutation if they haven’t been tested already.
  • Patients must have recovered from the serious side effects of prior therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are 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 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Ingo Mellinghoff at 866-886-9807.

Disease(s)
Brain Tumors, Primary: Gliomas
Solid Tumors
Locations
Related Diseases