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.
Who Can Participate?
Eligibility
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)
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase I/II Combination Study of NMS-03305293 and
Temozolomide in Adult Patients with Recurrent Glioblastoma
Temozolomide in Adult Patients with Recurrent Glioblastoma
Principal Investigator
Katherine
Peters
Protocol Number
PRO00115326
NCT ID
NCT04910022
Phase
I/II
Enrollment Status
Pending Open to Enrollment