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

  Summary of Research

  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.

  Summary of Results

  The study was a Phase I/II trial in patients with locally advanced or metastatic unresectable iCCA harboring FGFR2 gene rearrangements including gene fusions. The trial’s primary endpoint in phase II part was objective response rate (ORR). The study met its primary endpoint. Futibatinib was safe and tolerable for the patients with a generally predictable, monitorable, and clinically manageable side effect profile.

• 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