NCT02796261

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: Orbus Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 approximately 36 months, or until patient death. A total of approximately 340 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.

Conditions

• Anaplastic Astrocytoma
• Recurrent Anaplastic Astrocytoma

Interventions

Type	Name	Description
DRUG	Eflornithine	Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule
DRUG	Lomustine	Lomustine 90 mg/m2 administered orally once every 6 weeks
DRUG	Lomustine	Lomustine 110 mg/m2 administered orally once every 6 weeks

Timeline

• Start date: 2016-07-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2016-06-10
• Last updated: 2022-01-21

Locations

79 sites across 8 countries: United States, Belgium, Canada, France, Germany, Italy, Netherlands, United Kingdom