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Glioblastoma, IDH-wildtypeCancerDrugPhase 1

What this study is

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.

What's being tested

  • Eflornithine (Dose Level 1)

    Intervention · DRUG

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

  • Eflornithine (Dose Level 2)

    Intervention · DRUG

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

  • Eflornithine (Dose Level -1)

    Intervention · DRUG

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

  • Temozolomide

    Intervention · DRUG

    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 details

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
Sponsor
Orbus Therapeutics, Inc.
Conditions
Glioblastoma, IDH-wildtype · Glioblastoma · Glioblastoma Multiforme · Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype · GBM · Astrocytoma · Astrocytoma, IDH-Mutant
Enrolling
66 people
Starts
2023-07-24
Est. completion
2026-06-30
Design
Open-label, non-randomized, sequential groups, Phase 1
Record
View on ClinicalTrials.gov ↗