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

    Lucy.Brazil@gstt.nhs.uk

  • Sponsor organisation

    Orbus Therapeutics, Inc.

  • Eudract number

    2016-000089-45

  • Clinicaltrials.gov Identifier

    NCT02796261

  • 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 weeks

    Approximately 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 months

    Patients 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