A Phase I Study Finding the Best Dose of AMG 232 (KRT 232) Combined with Radiation Therapy in Patients with Brain Cancer

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Full Title

Phase 0/I Study of AMG 232 Concentrations in Brain Tissue in Patients with Recurrent Glioblastoma and of AMG 232 in Combination with Radiation in Patients with Newly Diagnosed Glioblastoma and Unmethylated MGMT Promoters (ABTC 1604)

Purpose

One reason chemotherapy may not work well to treat brain tumors is that it is difficult for many drugs to penetrate brain tissue. In this study, researchers want to find the highest dose and dosing schedule of AMG 232 (KRT 232) that can be given safely to people with brain cancer who are receiving standard radiation therapy.

AMG232 (KRT 232) works by binding to and activating a protein called TP53. When it works properly, TP53 helps regulate cells, causing them to die. Researchers have found that AMG232 (KRT 232) is more likely to be effective in people who do not have an altered (mutated) form of TP53. AMG232 (KRT 232) 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 be newly diagnosed with glioblastoma with unmethylated MGMT status and have normal TP53.
  • Patients may have had prior brain tumor surgery, but no other therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older

For more information about this study and to inquire about eligibility, please contact Dr. Anna Piotrowski at 212-610-0483.

Protocol

19-337

Phase

0

Investigator

Co-Investigators