A Phase I Study of AZD1390 plus Radiation Therapy in Patients with Glioblastoma Multiforme or Brain Metastases

Full Title

D6940C00002: A Phase I, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending Doses of AZD1390 in Combination with Radiation Therapy in Patients with Glioblastoma Multiforme and Brain Metastases from Solid Tumors

Purpose

The purpose of this study is to find the highest dose of the investigational drug AZD1390 that can be given in combination with radiation therapy in patients with glioblastoma multiforme (an aggressive type of brain cancer), or brain metastases or leptomeningeal metastases (cancer that has spread to the brain from a solid tumor elsewhere in the body).

Radiation kills cancer cells by damaging tumor DNA, the genetic material in cancer cells. Cancer cells can often avoid death by repairing damaged tumor DNA. ATM is an important protein that helps to repair damaged tumor DNA. AZD1390 is designed to block the ability of ATM to repair tumor DNA, therefore enhancing the chance that radiation can kill cancer cells.

In this study, researchers will evaluate AZD1390 plus radiation therapy in three groups of patients:

  • Patients with glioblastoma multiforme that has been treated but is growing (recurrent glioblastoma multiforme).
  • Patients with newly diagnosed glioblastoma multiforme who have not previously received treatment for it.
  • Patients with brain metastases or leptomeningeal metastases.

AZD1390 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 glioblastoma multiforme or brain metastases and fit into one of the three groups described above.
  • 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. T. Jonathan Yang at 212-639-8157.

Protocol

18-191

Phase

I

Investigator

Co-Investigators