Study of Acalabrutinib and Vistusertib in B-cell malignancies

  • Research type

    Research Study

  • Full title

    A Phase 1/2 Proof-of-Concept Study of the Combination of Acalabrutinib and Vistusertib in Subjects with Relapsed/Refractory B-cell Malignancies



  • Contact name

    Graham Collins

  • Contact email

  • Sponsor organisation

    Acerta Pharma BV

  • Eudract number


  • Identifier

    133812, IND NUMBER

  • Duration of Study in the UK

    2 years, 7 months, 30 days

  • Research summary

    The advent of targeted agents to treat B cell malignancies has changed the risk:benefit paradigm traditionally associated with chemotherapy regimens. The question remains whether targeted combination therapy can produce more durable responses than single agents without an undue associated increase in toxicity. This proof-of-concept study will assess the clinical potential of acalabrutinib and vistusertib in subsets of relapsed/refractory B-cell malignancies. Participating sites are onco-haematology clinics with previous experience in early phase clinical trials and with adequate staff and facilities. Eligible subjects will be treated for up to 12 months. Archival tumour tissue must be available. Subjects will undergo routine blood tests,PET-CT and high-resolution contrast CT scans every 8 weeks to assess the response to treatment. Subjects will also undergo a PET scan at screening and whenever deemed necessary by the PI in order to assess tumour response. Subjects will be asked to complete a dosing diary for their treatment, which is to be taken orally twice a day. Subjects may also be included in a pharmacogenetics and a fresh tumour biopsies sub-studies, on a voluntary basis.

  • REC name

    South Central - Oxford C Research Ethics Committee

  • REC reference


  • Date of REC Opinion

    12 May 2017

  • REC opinion

    Favourable Opinion