An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

Prior treatment

• Received a prior IDH1 inhibitor
• Have received a transplant
• Have received systemic cancer treatment or radiotherapy within 2 weeks prior to Day 1 of Cycle 1
• Have received hepatic radiation, chemoembolization, and radiofrequency ablation within 4 weeks prior to Day 1 of Cycle 1
• Have ongoing brain metastases requiring steroids
• Have underwent major surgery within 4 weeks of Day 1 of Cycle 1 prior to C1D1

Other illness

• Have an active hepatitis B (HBV) or hepatitis C (HCV) infections, known positive human immunodeficiency virus (HIV) antibody results, or acquired immunodeficiency syndrome (AIDS) related illness

Other

• Are pregnant or breastfeeding

• Diagnosis of nonresectable or metastatic Cholangiocarcinoma (CCA), not eligible for curative-intent resection, transplantation, or ablative therapies
• Have a documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease
• Have tried at least 1 prior type of systemic therapy for CCA, and have recovered from any side effects
• Female patients of childbearing potential must have a negative blood pregnancy test prior to starting treatment and must agree to use 2 forms of contraception from the time they enroll to 1 month after their last dose of study drug
• Male patients with a female partner with childbearing potential must also agree to use 2 forms of contraception from the time they enroll to 1 month after their last dose of study drug