A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic strocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy STELLAR Study
The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.
Key Inclusion Criteria:
-Surgical or biopsy-proven diagnosis of WHO grade 3 AA.
-First AA tumor progression or recurrence ≤ 6 months prior to randomization based on MRI using T2 hyperintesity, gadolinium (Gd)-contrast enhancement, or both. To avoid enrollment of patients with glioblastoma, patients with Gd-contrast enhancing tumors will be eligible if there is no necrosis seen on MRI and any of the following criteria is true:
1.Gd-contrast lesion margins are not clearly defined,
2.Gd-contrast lesions are only measurable in one dimension,
3.Gd-contrast lesion has two perpendicular diameters less than 10 mm,
4.Gd-contrast lesion has two perpendicular diameters greater than 10 mm but less than 20 mm and lesion does not demonstrate central necrosis,
5.Recent histopathological confirmation of WHO grade 3 AA
-Received EBRT and temozolomide chemotherapy prior to first tumor progression or recurrence of WHO Grade 3 AA.
-Completion of EBRT ≥ 6 months prior to randomization.
Key Exclusion Criteria:
-MRI defining progression is consistent with a diagnosis of glioblastoma or radiation necrosis.
-Patients who are considered to be refractory to EBRT and temozolomide but who have not progressed.
-Prior systemic therapy for recurrence of AA.
-Presence of extracranial or leptomeningeal disease.
-Prior lomustine use.
**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Ricky Chen, M.D.
Orbus Therapeutics, Inc.