A Phase 2 Study of Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

Inclusion Criteria: * Have nonresectable or metastatic cholangiocarcinoma and are not eligible for curative resection, transplantation or ablative therapies * Have documented IDH1 gene-mutated disease from a tumor biopsy * Have an ECOG PS score of 0 or 1 * Have an expected survival of 3 months or more * Have at least one evaluable and measurable lesion * Have disease progression following the most recent of 1 or 2 prior systemic regimens for advanced disease with progression on the treatment that was most recently given at a minimum, and must have received at least 1 gemcitabine- or 5-FU -containing regimen * Have recovered from side effects associated with the prior treatment therapy * Have adequate bone marrow function * Have adequate hepatic (liver) and renal (kidney) function * Women of child bearing potential must have a negative serum pregnancy test before starting study treatment, and use birth control during the study and for 90 days after the last dose of ivosidenib * Fertile men with female partners of child bearing potential must use birth control during the study and for 90 days after the last dose of ivosidenib Exclusion Criteria: * Received a prior IDH inhibitor. * Have known symptomatic brain metastases requiring steroids. * Pregnancy, possibility of becoming pregnant during the study and breast-feeding women or woman who plans to restart breast-feeding after the study drug administration/intake. * Are taking known strong cytochrome P450 (CYP) 3A4 inducers o…