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

Recruiting Phase 1 Interventional Study
Glioblastoma, IDH-wildtype Glioblastoma Glioblastoma Multiforme Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype GBM Astrocytoma Astrocytoma, IDH-Mutant
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
66 (estimated)
Sponsor
Orbus Therapeutics, Inc. · Industry
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About 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 or astrocytoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.

Trial Locations
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Eligibility Criteria
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…
Contacts

Monika Varga

6506569424

monika.varga@orbustherapeutics.com

CONTACT