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  • TAIHO solid

    Acronym: 

    TPU-TAS-120-101

    ACTRN/NCT /ethics: 

    NCT02052778

    Scientific title: 

    A study of TAS-120 in patients with advanced solid tumours

    Summary of trial and patient characteristics

    Cancer Type All cancers
    Trial Type Treatment
    Phase Phase II, Phase I Tumour Stream Solid tumours
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced
    Sex Both Anticipated Start Date 2014-07-01
    Molecular Target Anticipated End Date 2019-09-01
    Cancer Type All cancers
    Trial Type Treatment
    Phase Phase II, Phase I
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Solid tumours
    Cancer Stage Locally Recurrent or Locally Advanced
    Anticipated Start Date 2014-07-01
    Anticipated End Date 2019-09-01

    Trial Summary

    This is an open-label, nonrandomized, Phase 1 dose-escalation, dose-expansion, and Phase 2 study targeting tumors with FGF/FGFR aberrations. The purpose of the study is to evaluate the safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of TAS-120 in patients with advanced solid tumors with and without FGF/FGFR-related abnormalities. The study will be conducted in 3 parts, (1) Dose escalation to determine the MTD and/ or RP2D of TAS-120 in which this part of the study has been completed; (2) Phase 1 expansion to further evaluate the safety and efficacy of RP2D of TAS-120 in patients with tumors harboring specific FGFR aberrations, specifically in patients with cholangiocarcinoma, gliomas , urothelial carcinomas and any other tumors with FGFR fusion or activating mutation or amplification. Up to approximately 185 patients will be enrolled in the phase 1 expansion; and (3) Phase 2 study to confirm ORR of TAS-120 in intra-hepatic CCA patients with tumors harboring FGFR2 gene fusions. Approx. 100 patients will be enrolled in phase 2.

    Lay Summary

    A study of TAS-120 in patients with advanced solid tumours

    Sponsor / Cooperative group

    Taiho Oncology Inc.

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Chris Karapetis Not Yet Recruiting