drugset / Trial / NCT05879367

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

NCT05879367

Phase 1 Recruiting 66 enrolled Orbus Therapeutics, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

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

Timeline

Start
2023-07-24
Primary completion
2026-06-30
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Eflornithine Small molecule 1750 mg/m2 Oral
Subject Eflornithine Small molecule 2300 mg/m2 Oral
Subject Eflornithine Small molecule 2800 mg/m2 Oral
Subject Temozolomide Small molecule 150 mg/m2 Oral