520-215 AfFIRM A Phase 2 Trial of Filanesib in Relapsed/Refractory MM

  • Research type

    Research Study

  • Full title

    A Multicenter Phase 2 Study of Single-agent Filanesib (ARRY-520) in Patients With Advanced Multiple Myeloma

  • IRAS ID

    156877

  • Contact name

    Martin Kaiser

  • Contact email

    martin.kaiser@icr.ac.uk

  • Sponsor organisation

    Array BioPharma Inc.

  • Eudract number

    2014-001051-23

  • Research summary

    An unmet medical need exists for patients with multiple myeloma whose disease has progressed despite treatment with various different therapies.
    This need may be addressed with new drugs such as Filanesib due to the way it works.
    Cancer cells contain 2 different types of proteins. One of which help the cells to survive and one of which allows them to die. When these proteins are well balanced within the cancer cells it allows the disease to continue to progress.
    Filanesib works by binding to and suppressing the proteins in the cancer cells which help them to survive meaning that only the proteins that allow the cancer cells to die will remain present.
    To be eligible to participate in the study patients must be over 18 years old and have a confirmed diagnosis of multiple myeloma for which they must have received 2 prior types of treatment.
    The study will consist of a 4 week screening phase followed by several 28 cycles of treatment for patients who pass the screening phase.
    Study assessments will include: Physical examinations, blood and urine tests, bone marrow aspirate or biopsy and radiological scans.

  • REC name

    London - West London & GTAC Research Ethics Committee

  • REC reference

    14/LO/1444

  • Date of REC Opinion

    20 Oct 2014

  • REC opinion

    Further Information Favourable Opinion