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RECRUITING
NCT05879367
PHASE1

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

Sponsor: Orbus Therapeutics, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2023-07-24

Completion Date

2026-06-30

Last Updated

2025-06-25

Healthy Volunteers

No

Interventions

DRUG

Eflornithine (Dose Level 1)

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

DRUG

Eflornithine (Dose Level 2)

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

DRUG

Eflornithine (Dose Level -1)

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

DRUG

Temozolomide

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