Clinical Trial: Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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 Adjuv
Brief 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 Summary:
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.
Sponsor: Orbus Therapeutics, Inc.
Current Primary Outcome: Overall survival [ Time Frame: 4 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Progression-free survival (PFS) [ Time Frame: 4 years ]
- Objective response rate (ORR) [ Time Frame: 4 years ]
Original Secondary Outcome: Same as current
Information By: Orbus Therapeutics, Inc.
Dates:
Date Received: June 3, 2016
Date Started: July 2016
Date Completion: August 2019
Last Updated: May 23, 2017
Last Verified: May 2017
