RecruitingPhase 1NCT05879367

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

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.

Enrollment

66 participants

Start Date

Jul 24, 2023

Study Type

INTERVENTIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria8

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.

Interventions

DRUGEflornithine (Dose Level 1)

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

DRUGEflornithine (Dose Level 2)

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

DRUGEflornithine (Dose Level -1)

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

DRUGTemozolomide

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