PROOF

A Phase II, Single Arm Study of BGJ398 (infigratinib) in patients with advanced cholangiocarcinoma.

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”

This is a single-arm, open-label, Phase 2 international trial for infigratinib for those with advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions/translocations, or other FGFR genetic alterations who also:

  • Show evidence of radiologic progression following a gemcitabine + cisplatin regimen for advanced disease

or

  • Have been treated with a gemcitabine-containing regimen, but cannot tolerate cisplatin

March 2020: This trial remains open and is enrolling patients previously treated with an FGFR inhibitor, and patients with alterations other than FGFR2 fusions.

Amended Cohorts of the Second-line Trial

  • Cohort 1: patients with FGFR2 gene fusions or translocations
  • Cohort 2: patients with FGFR genetic alterations other than FGFR2 gene fusions or translocations
  • Cohort 3: patients with FGFR2 gene fusions or translocations who have received a prior FGFR inhibitor

All patients will receive oral infigratinib, once daily, on a schedule of 3 weeks on (21 days), 1 week off (7 days). One treatment cycle consists of 28 days.

FGFR = fibroblast growth factor receptor.

This trial is currently open and recruiting in the UK at:

  • Nottingham City Hospital, NG5 1PB
    Nottingham University Hospitals NHS Trust

Contact: Jeanette Martin / Contact: Caroline Coulson
Tel:  +44 115 969 1169 ext 58369
Principal Investigator: Dr Ankit Rao

For more information see:
https://clinicaltrials.gov/ct2/show/NCT02150967

Also, see:
https://bepartofresearch.nihr.ac.uk/ and search for Study: NCT02150967

QED:  https://www.qedtx.com/cholangiocarcinoma/

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