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

NCT05879367 · tracked via the Priya Life Science USA tracker

Sponsor

Orbus Therapeutics, Inc.

Phase

Phase 1

Started

2023-07-24

Last updated

2025-06-25

Condition(s) studied

Glioblastoma, IDH-wildtypeGlioblastomaGlioblastoma MultiformeGlioblastoma IDH (Isocitrate Dehydrogenase) WildtypeGBMAstrocytomaAstrocytoma, IDH-Mutant

Investigational drug(s) / intervention(s)

Eflornithine (Dose Level 1)Eflornithine (Dose Level 2)Eflornithine (Dose Level -1)Temozolomide

Eflornithine (Dose Level 1): Eflornithine 2.3 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule

Eflornithine (Dose Level 2): Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule

Eflornithine (Dose Level -1): Eflornithine 1.75 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule

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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 TMZ during chemoradiation. Patients with astrocytoma: Must have tolerated adjuvant TMZ treatment through at least 2 and not more than 4 cycles. * 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 other than temozolomide during external beam radiation therapy (for patients with GBM) or adjuvant temozolomide through up to 4 pre-study cycles (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.

Primary outcome measure(s)

Assessment of Dose Limiting Toxicities — 8 weeks
Protocol Defined Dose Limiting Toxicities
Incidence of TEAEs All Grades — From enrollment to the follow-up visit 4 weeks after end of treatment
All Grades
Incidence of TEAEs Grade 3+ — From enrollment to the follow-up visit 4 weeks after end of treatment
Grade 3+
Incidence of TEAEs Serious — From enrollment to the follow-up visit 4 weeks after end of treatment
Serious
Incidence of TEAEs Leading to Discontinuation — From enrollment to the end of treatment
Leading to Discontinuation
Vital Signs (Heart and Respiratory Rate) — From enrollment to the follow-up visit 4 weeks after end of treatment
Change from Baseline in Heart Rate and Respiratory Rate
Vital Signs (Blood Pressure) — From enrollment to the follow-up visit 4 weeks after end of treatment
Change from Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
Incidence of Treatment-Emergent Abnormalities in Clinical Laboratory Tests — From enrollment to the follow-up visit 4 weeks after end of treatment
Lab abnormalities by CTCAE v5.0 Grade

Trial sites (8)

Facility	City	Region	Status
University of Alabama at Birmingham	Birmingham	Alabama	Withdrawn
Henry Ford Hospital	Detroit	Michigan	Recruiting
Columbia University Medical Center - Herbert Irving Pavilion	New York	New York	Recruiting
Duke University	Durham	North Carolina	Recruiting
The Cleveland Clinic	Cleveland	Ohio	Recruiting
Brown University Health/Rhode Island Hospital	Providence	Rhode Island	Recruiting
UT MD Anderson Cancer Center	Houston	Texas	Recruiting
University of Utah, Huntsman Cancer Institute	Salt Lake City	Utah	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05879367 on ClinicalTrials.gov ↗ ← All trials in the USA