Vertex VX13-970-002

  • Research type

    Research Study

  • Full title

    An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of VX-970 as a Single Agent and in Combination With Carboplatin in Subjects With Advanced Solid Tumors.

  • IRAS ID

    148591

  • Contact name

    Johann de Bono

  • Contact email

    johann.debono@icr.ac.uk

  • Sponsor organisation

    Vertex Pharmaceuticals (Europe) Ltd.

  • Eudract number

    2013-005100-34

  • Duration of Study in the UK

    1 years, 9 months, 7 days

  • Research summary

    Chemotherapy and radiation that induce DNA damage to cancer cells are an effective and common treatment for people with many types of solid tumours. However, many cancers, despite displaying initial response to these agents will ultimately progress. One mechanism that has been proposed to protect cancer cells from DNA damage is the DNA damage response (DDR) pathway that is regulated by certain enzymes called kinases. In many cancer cells, these enzymes play a crutial role in protecting cancer cells from DNA damage and subsequently cell death. Therefore inhibiting these enzymes should enhance the effect of DNA damaging chemotherapy on cancer cells.

    This is a phase-1 clinical study using VX-970. It will look at the safety, tolerability and mechanisms of action of VX-970. This will be done with VX-970 as a single drug and also in combination with another drug called carboplatin.

    The study will be conducted in 3 parts:
    Part A will identify the highest safe dose (also called Maximum Tolerated Dose, MTD) of VX-970 when taken alone.

    Part B will identify the MTD of VX-970 when used in combination with carboplatin.

    Part C will be an expansion cohort to evaluate the tolerability and antitumour activity of VX-970 as a single drug, followed by VX-970 in combination with carboplatin.

    The study will involve approximately 28-40 subjects.
    Approximately 16 in Part A with advanced solid tumours (where possible with defects of DNA damage response)
    Approximately 12 in Part B with advanced solid tumours
    Approximately 12 in Part C with advanced triple negative breast cancer, high grade serious ovarian cancer or other cancers with known defects in the DNA damage response that have exhibited sensitivity to VX-970 in Parts A or B of this study or in any other ongoing study.

  • REC name

    London - Chelsea Research Ethics Committee

  • REC reference

    14/LO/0372

  • Date of REC Opinion

    16 Apr 2014

  • REC opinion

    Further Information Favourable Opinion