A Phase IB/II Study of BGB-290 with Temozolomide in Glioblastoma

Full Title

A Phase 1b/2 Study to Assess the Safety, Tolerability and Efficacy of BGB-290 in Combination with Radiation Therapy and/or Temozolomide in Subjects with First-Line or Recurrent/Refractory Glioblastoma

Purpose

Temozolomide is a standard treatment for glioblastoma, but does not work well in all patients, particularly those with a molecular marker called “unmethylated MGMT.” Doctors are interested in learning if adding the investigational drug BGB-290 to temozolomide can make treatment more effective in patients with glioblastoma. In this study, researchers are determining the highest doses of these two drugs that can be given together safely, in addition to radiation therapy, in patients with newly diagnosed glioblastoma that has not yet been treated with anything other than surgery or recurrent glioblastoma that has been treated with standard radiation and temozolomide.

Temozolomide is designed to work by damaging DNA in cancer cells, which prevents the cancer from growing. BGB-290 prevents cancer cells from repairing their damaged DNA by inhibiting a DNA repair protein called PARP, causing them to die. It is hoped that temozolomide will be more effective against glioblastoma cells when it is given in combination with BGB-290. Both medications are 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 that has only been treated with surgery OR glioblastoma that came back or continued to grow despite prior treatment with radiation and temozolomide.
  • In patients with newly diagnosed glioblastoma, tumors must have the unmethylated MGMT biomarker. In patients with recurrent glioblastoma, tumors may have methylated or unmethylated MGMT biomarkers.
  • 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. Anna Piotrowski at 212-610-0483.

Protocol

18-301

Phase

I/II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators