Eflornithine + Temozolomide for Glioblastoma

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen ByHoward Colman, MD, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Orbus Therapeutics, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

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

Eligibility Criteria

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.

Participant Groups

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.

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

Eflornithine is already approved in European Union, United States, United States for the following indications:

🇪🇺 Approved in European Union as Vaniqa for: