Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma

Inclusion Criteria:

• Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype (patients with GBM) or G3 astrocytoma (IDH1 or 2 mutant; CDKN2A/B intact) per WHO 2021 tumor classification.

• Completed external beam radiation therapy per standard of care.

• Patients with GBM: Must have received at least 80% of planned daily doses of TMZduring chemoradiation. Patients with astrocytoma: Must have tolerated adjuvant TMZtreatment through at least 2 and not more than 4 cycles.

• Adequate hematologic, renal, hepatic, and other organ function as indicated byhematology and serum chemistry testing.

• Willing to abstain from intercourse or use acceptable contraceptive methods.

• If taking corticosteroids, must be on a stable or decreasing dose.

Exclusion Criteria:

• Recent history of recurrent or metastatic cancer that could confound responseassessments

• Prior systemic chemotherapy other than temozolomide during external beam radiationtherapy (for patients with GBM) or adjuvant temozolomide through up to 4 pre-studycycles (for patients with astrocytoma).

• Prior Optune treatment.

• Active infection or serious intercurrent medical illness.

• Poorly controlled seizures.

• Significant cardiac disease within 6 months of enrollment.

• Poorly controlled diabetes.

• Use of another investigational agent within 30 days of enrollment.