PHASE I/II STUDY IN ADVANCED SOLID TUMOURS or MULTIPLE MYELOMA TAS-120

• Research type

  Research Study

• Full title

  PHASE 1/2 STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS HARBORING FGF/FGFR ABERRATIONS

• IRAS ID

  143913

• Contact name

  Elisa Fontana

• Contact email

  Elisa.Fontana@hcahealthcare.co.uk

• Sponsor organisation

  Taiho Oncology Inc

• Eudract number

  2013-004810-16

• Clinicaltrials.gov Identifier

  NCT02052778

• Duration of Study in the UK

  6 years, 10 months, days

• Research summary

  This is a clinical research study of TAS-120 (study drug) which is a drug under investigation. This means that TAS-120 has not been approved for use in any country, except in a clinical research study. TAS-120 is an investigational Fibroblast Growth Factor/Receptor (FGF/FGFR) inhibitor which may stop the growth of certain cancer cells in humans. This may help in the treatment of advanced cancer. FGF/FGFR is a marker that is present in some cancers for example, non-small cell lung cancer, breast, gastric, bladder, endometrial and also multiple myeloma and rhabdomyosarcoma. FGFR gene abnormalities are considered a driving event for tumour formation.
  In all the tumour types described above for which FGF/FGFR abnormalities have been described, non-resectable (i.e. the tumour cannot be successfully removed by surgery), advanced or metastatic disease remains incurable and ultimately resistant to currently available chemotherapies.
  There are three parts to this study: Phase 1 dose escalation, Phase 1 expansion, and Phase 2

  The purpose of the Phase 1 dose escalation part is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-cancer activity of TAS-120 and to find the appropriate dose and dosing regimen of TAS-120 to be used in the later parts of the study (Phase 1 expansion and Phase 2). Pharmacokinetics allows us to examine how the body processes a drug (i.e., what the body does to the drug) and pharmacodynamics allows us to find out how the body reacts to a drug (i.e., what the drug does to the body). The purpose of Phase 1 expansion and Phase 2 parts of the study is to determine the safety and efficacy of TAS-120 at the dose and dosing regimen chosen at the end of Phase 1 dose escalation.

• REC name

  London - Central Research Ethics Committee

• REC reference

  14/LO/0187

• Date of REC Opinion

  10 Apr 2014

• REC opinion

  Further Information Favourable Opinion