drugset / Trial / NCT02796261

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

NCT02796261

Phase 3 Unknown 343 enrolled Orbus Therapeutics, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2016-07
Primary completion
2023-06
Completion
2023-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Eflornithine Small molecule 2.8 g Oral
Comparator Lomustine Small molecule 90 mg/m2 Oral
Comparator Lomustine Small molecule 110 mg/m2 Oral