Study of oral BGJ398 in adult patients with cholangiocarcinoma

• Research type

  Research Study

• Full title

  A phase II multicenter, single arm study of oral BGJ398 in adult patients with advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions or other FGFR genetic alterations who failed or are intolerant to platinum-based chemotherapy

• IRAS ID

  257917

• Contact name

  Yuk Ting Ma

• Contact email

  YukTing.Ma@uhb.nhs.uk

• Sponsor organisation

  QED Therapeutics, Inc.

• Eudract number

  2013-005085-19

• Clinicaltrials.gov Identifier

  NCT02150967

• Duration of Study in the UK

  2 years, 3 months, 18 days

• Research summary

  This study is designed to evaluate the efficacy of the targeted, selective pan-FGFR inhibitor BGJ398 when administered as a single agent to patients with genetically selected advanced or metastatic cholangiocarcinoma through estimation of the overall response rate. Molecular characterization of these tumors at baseline and at the time of progression may allow for increased understanding of potential treatment combinations, as well as primary and acquired resistance mechanisms.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  19/EM/0099

• Date of REC Opinion

  13 Jun 2019

• REC opinion

  Further Information Favourable Opinion