Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients

Official Title

A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy

Summary:

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.

Trial Description

Primary Outcome:

• Overall survival

Secondary Outcome:

• Progression-free survival (PFS)
• Objective response rate (ORR)

This study will consist of 4 study periods of up to 50 months in total, consisting of:

• Screening Period - A maximum screening duration of 4 weeks.
• Treatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.
• End of Treatment Visit - A minimum of 4 weeks post last treatment for both arms.
• Follow-Up Period - Up to 24 months. A total of approximately 280 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.

View this trial on ClinicalTrials.gov