Clinical trial · Interventional
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
NCT05879367CI-TRIAL-00091327recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma | Astrocytoma | CURATED_BROADER | 0.80 |
| Astrocytoma, IDH-Mutant | Astrocytoma, IDH-Mutant | ONTOLOGY_EXACT | 0.90 |
| GBM | Glioblastoma | ALIAS | 0.90 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype | — | UNRESOLVED | — |
| Glioblastoma, IDH-wildtype | Glioblastoma, IDH-Wildtype | ONTOLOGY_EXACT | 0.90 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eflornithine (Dose Level 1) | Drug | — | UNRESOLVED |
| Eflornithine (Dose Level 2) | Drug | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Eflornithine Dose Level 1 + Temozolomide
- interventionNames
- Drug: Eflornithine (Dose Level 1)
- Drug: Temozolomide
- type
- EXPERIMENTAL
- label
- Eflornithine Dose Level 2 + Temozolomide
- interventionNames
- Drug: Eflornithine (Dose Level 2)
- Drug: Temozolomide
- type
- EXPERIMENTAL
- label
- Eflornithine Dose Level -1 + Temozolomide
- interventionNames
- Drug: Eflornithine (Dose Level -1)
- Drug: Temozolomide
Primary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.