INCYTE, Efficacy and Safety of INCB054828 in Cholangiocarcinoma

• Research type

  Research Study

• Full title

  A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Translocations Who Failed Previous Therapy

• IRAS ID

  220257

• Contact name

  Harpreet Wasan

• Contact email

  h.wasan@imperial.ac.uk

• Sponsor organisation

  Incyte Corporation

• Eudract number

  2016-002422-36

• Duration of Study in the UK

  1 years, 4 months, 1 days

• Research summary

  This is an open-label, monotherapy (single therapy) study of INCB054828 in subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocations, with other FGF/FGFR alterations, or who are negative for FGF/FGFR alterations.

  The study drug INCB054828 is an inhibitor of the fibroblast growth factor receptor (FGFR) family of receptor tyrosine kinases. Fibroblast growth factor receptor signalling contributes to the developing of malignancies by promoting tumour cell proliferation (rapid growth), survival, migration, and angiogenesis (development of new blood vessels).

  Subjects will sign a pre-screening informed consent form and a tumour biopsy will be evaluated by a central laboratory (Foundation Medicine) for FGF/FGFR gene alteration status. Following documentation of the subject's FGF/FGFR alteration status, the subject will then undergo screening and if they meet the rest of the inclusion/exclusion criteria, they will be enrolled into the study into 1 of 3 groups:
  • Cohort A: FGFR2 translocations
  • Cohort B: other FGF/FGFR alterations
  • Cohort C (US only): negative for FGF/FGFR alterations

  Treatment will start on Day 1. Subjects will receive a once daily dose of INCB054828 at 13.5 mg on a 2-week-on therapy and 1-week-off therapy schedule.

  Subjects will undergo regular safety assessments during treatment as well as regular efficacy assessments. Subjects will be allowed to continue administration in 21-day cycles until documented disease progression or unacceptable toxicity is reported.

  The study will enrol approximately 100 subjects in total. This study is sponsored by Incye Corporation.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  17/NW/0180

• Date of REC Opinion

  3 Apr 2017

• REC opinion

  Further Information Favourable Opinion