Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma

• Status: Recruiting
• Trial end date: 2024-12-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orbus Therapeutics, Inc.
• Treatments: Eflornithine; Temozolomide

Criteria

Inclusion Criteria:

• Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype per WHO 2021 tumor classification.

• Completed external beam radiation therapy per standard of care.

• Must have received at least 80% of planned daily doses of TMZ during chemoradiation.

• Adequate hematologic, renal, hepatic, and other organ function as indicated by hematology 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 response assessments

• Prior systemic chemotherapy for GBM other than temozolomide during external beam radiation therapy.

• 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.