Adult patients with histologically or cytologically confirmed advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions or translocations or other FGFR genetic alterations have been enrolled. Subjects must have received at least one prior regimen containing gemcitabine with or without cisplatin for advanced/metastatic disease. Subjects should have had evidence of progressive disease following their prior regimen or if prior treatment was discontinued due to toxicity must have continued evidence of measurable disease. Up to approximately 160 adult patients over age 18, both male and female were planned for enrollment.~Three cohorts of subjects comprise the study population:~Cohort 1: subjects with FGFR2 gene fusions (ie, fusions or rearrangements [formerly translocations]) and those with other FGFR genetic alterations (ie, nonfusion; these subjects were enrolled before protocol amendment [PA] 2).~Cohort 2: subjects with FGFR genetic alterations other than FGFR2 gene fusions or rearrangements.~Cohort 3: subjects with FGFR2 gene fusions or rearrangements who have received a prior FGFR inhibitor.~Note: Cohorts 2 and 3 were added at PA 4 to support exploratory objectives of the study. These cohorts are not part of the primary efficacy analysis reported in this disclosure.~All subjects received oral BGJ398 (infigratinib), once-daily, on a three weeks on (21 days), one week off (7 days) schedule. One treatment cycle consists of 28 days.
This is a multi-center, open label, single arm phase II study evaluating BGJ398 (infigratinib) anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with fibroblast growth factor receptor (FGFR) genetic alterations.