An Open-label, Phase 1b Study to Evaluate the Safety and Tolerability of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma

Trial ID: NCT05879367

Interventional - Phase 1 - Recruiting

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.

Conditions

• Glioblastoma, IDH-wildtype
• Glioblastoma
• Glioblastoma Multiforme
• Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
• GBM
• Astrocytoma
• Astrocytoma, IDH-Mutant

Interventions

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

Eligibility

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.

Sponsor

Orbus Therapeutics, Inc.

Source: ClinicalTrials.gov

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