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Anti-cancer agent

Eflornithine + Temozolomide for Glioblastoma

Phase 1
Recruiting
Led By Howard Colman, MD, PhD
Research Sponsored by Orbus Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug combo to treat newly-diagnosed glioblastoma to see if it's safe & effective.

Who is the study for?
This trial is for adults with a specific brain cancer called glioblastoma (GBM), IDH-wildtype, who have finished radiation therapy and most of their initial chemo with temozolomide. They need good blood, kidney, liver function and agree to use birth control. It's not for those with recent serious heart issues, uncontrolled diabetes or other cancers, active infections, prior Optune treatment or poorly controlled seizures.
What is being tested?
The study tests different doses of Eflornithine in combination with Temozolomide to find the safest and most effective dose for treating newly diagnosed GBM patients. The goal is also to check how well patients tolerate this drug combo.
What are the potential side effects?
Possible side effects include typical reactions from chemotherapy like nausea, vomiting, fatigue, hair loss and increased risk of infection due to lowered white blood cell counts. Specific side effects related to Eflornithine are not detailed but may be similar.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessment of Dose Limiting Toxicities
Incidence of TEAEs All Grades
Incidence of TEAEs Grade 3+
+5 more
Secondary study objectives
Assessment of QTcF
Overall Response Rate
Pharmacokinetics AUCt
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Eflornithine Dose Level 2 + TemozolomideExperimental Treatment2 Interventions
Group II: Eflornithine Dose Level 1 + TemozolomideExperimental Treatment2 Interventions
Group III: Eflornithine Dose Level -1 + TemozolomideExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

Orbus Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
343 Total Patients Enrolled
Howard Colman, MD, PhDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
1 Previous Clinical Trials
33 Total Patients Enrolled

Media Library

Eflornithine (Anti-cancer agent) Clinical Trial Eligibility Overview. Trial Name: NCT05879367 — Phase 1
Solid Tumors Research Study Groups: Eflornithine Dose Level 2 + Temozolomide, Eflornithine Dose Level -1 + Temozolomide, Eflornithine Dose Level 1 + Temozolomide
Solid Tumors Clinical Trial 2023: Eflornithine Highlights & Side Effects. Trial Name: NCT05879367 — Phase 1
Eflornithine (Anti-cancer agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05879367 — Phase 1
~28 spots leftby Dec 2025
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