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

Prior treatment

• 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 or sensitive CYP3A4 substrate medications with a narrow therapeutic window
• Have significant heart disease, including congestive heart failure, myocardial infarction (heart attack) unstable angina (chest pain) and/or stroke, within 6 months before starting the study
• . Have active inflammatory gastrointestinal disease, chronic diarrhea, previous gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis (paralysis of the stomach), or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.

Other illness

• Have known medical history of progressive multifocal leukoencephalopathy (PML)

Lab values

• Have a heart-rate corrected QT interval ≥450 msec or other factors that increase the risk of QT prolongation or arrhythmic events

• 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