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NMS-03305293 and Temozolomide in Adult Patients with Recurrent Glioblastoma (PARPA-293-002) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an investigational drug called NMS-0330593 (the study drug) is safe and effective option when it is given in combination with temozolomide (an approved drug for the treatment of diffuse glioma). We want to know if this drug combination works better than temozolomide on its own.

What is the Condition Being Studied?

Intracranial Diffuse Glioma (Astrocytoma, Glioblastoma, or Oligodendroglioma)

Who Can Participate in the Study?

Adults ages 18+ who:

Are diagnosed with an intracranial diffuse glioma (i.e. diffuse astrocytoma, oligodendroglioma or glioblastoma)
Had their disease progress after initial standard therapy that included temozolomide
Have not received previous treatment with PCV (procarbazine, lomustine, and vincristine) or any of its components (carmustine wafer implants or bevacizumab)
Have not received previous treatment with PARP inhibitors (poly (ADP-ribose) polymerase)
Do not take enzyme-inducing anti-epileptic drugs (EIAED)

For more information, contact the study team at 919-684-5301.

Age Group

Adults

What is Involved?

If you choose to join this study, you will get the study drug along with temozolomide (an FDA approved drug). The dose of the study drug you receive will depend on when you enroll into the study. All study participants will receive the same dose of temozolomide.

You will continue to take the study drug regimen for as long as your and your doctor believe that you are getting a positive benefit.