At a glance
ClinicalIndex Comparison Record- ✓WHO G4 GBM IDH-wildtype or G3 astrocytoma IDH-mutant (CDKN2A/B intact)
- ✓Completed external beam radiation therapy per standard of care
- ✓GBM: ≥80% of planned TMZ doses during chemoradiation; Astrocytoma: tolerated adjuvant TMZ 2-4 cycles
- ✓Adequate hematologic, renal, hepatic, and organ function
- ✕Recent history of recurrent or metastatic cancer that could confound response assessments
- ✕Prior Optune treatment
- ✕Active infection or serious intercurrent medical illness
- ✕Poorly controlled seizures
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Phase 1b Study to Evaluate the Safety and Tolerability of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
In Brief
A Phase 1 clinical trial evaluating Eflornithine (Dose Level 1), Eflornithine (Dose Level 2), and 2 other interventions for Glioblastoma, IDH-wildtype and 6 related conditions. Currently recruiting, targeting 66 participants across 8 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
Eflornithine 2.3 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
Eflornithine 1.75 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule
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