RecruitingPhase 1NCT05879367

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

An Open-label, Phase 1b Study to Evaluate the Safety and Tolerability of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma


Sponsor

Orbus Therapeutics, Inc.

Enrollment

66 participants

Start Date

Jul 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding eflornithine (a drug that blocks a growth-related enzyme) to temozolomide (a standard chemotherapy) can improve outcomes in patients with newly diagnosed glioblastoma (grade 4 brain cancer) or certain grade 3 astrocytomas, after completing radiation therapy. **You may be eligible if...** - You have been diagnosed with grade 4 glioblastoma (IDH-wildtype) or grade 3 IDH-mutant astrocytoma - You have already completed radiation therapy with temozolomide (for GBM) or at least 2–4 cycles of adjuvant temozolomide (for astrocytoma) - Your blood counts and organ function are adequate - You are willing to use contraception **You may NOT be eligible if...** - You have had prior chemotherapy other than temozolomide - You have had prior Optune (electric field device) treatment - You have an active serious infection or cardiac disease within 6 months - You have poorly controlled diabetes or seizures - You used another investigational drug within 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEflornithine (Dose Level 1)

Eflornithine 2.3 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule

DRUGEflornithine (Dose Level 2)

Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule

DRUGEflornithine (Dose Level -1)

Eflornithine 1.75 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule

DRUGTemozolomide

Temozolomide 150 mg/m2 (with option to escalate per USPI maintenance phase instructions) administered orally once daily on a 5 days on, 23 days off schedule


Locations(8)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Henry Ford Hospital

Detroit, Michigan, United States

Columbia University Medical Center - Herbert Irving Pavilion

New York, New York, United States

Duke University

Durham, North Carolina, United States

The Cleveland Clinic

Cleveland, Ohio, United States

Brown University Health/Rhode Island Hospital

Providence, Rhode Island, United States

UT MD Anderson Cancer Center

Houston, Texas, United States

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT05879367


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