STELLAR Study of Eflornithine with Lomustine in Patients with AA
Research type
Research Study
Full title
A Phase 3, Randomised, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy.
IRAS ID
254087
Contact name
Lucy Brazil
Contact email
Sponsor organisation
Orbus Therapeutics, Inc.
Eudract number
2016-000089-45
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
68002, IND
Duration of Study in the UK
4 years, 7 months, 20 days
Research summary
Anaplastic Astrocytoma (AA) is a rare form of brain cancer (Who classification grade 3). The patient population for this study will have already received treatment for their brain cancer. If the brain cancer relapses following this initial treatment, they would then be eligible for this study. The current treatment for patients with recurrent disease is Lomustine.
In this study the objective is to see if Eflornithine usage along with Lomustine is superior to using Lomustine alone.
This study consists of the following treatments:
- Treatment Arm A: Eflornithine administered on a 2 week on, 1 week off schedule + Lomustine administered every 6 weeks
- Treatment Arm B: Lomustine administered every 6 weeksApproximately 280 patients in total are expected to be enrolled. 140 Patients in Treatment Arm A and 140 patients in Treatment Arm B.
The duration of the study is 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 monthsPatients will be recruited into the study at approximately 80 centres in North America and UK/Europe. 4 Sites will take part in the study in the UK.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0057
Date of REC Opinion
21 Mar 2019
REC opinion
Favourable Opinion