Pancreatic cancer is the twelfth most common cancer but is the third leading cause of cancer death in the United States. The 5-year survival is just 3% for those with metastatic disease and 34% with localized disease, the worst of the common cancers. Currently, standard of care for patients with pancreatic cancer is surgical removal followed by chemotherapy. However, approximately only half of all patients complete chemotherapy after surgery. In an attempt to increase the rate of patients receiving chemotherapy after surgery, which extends patient survival significantly, and to positively impact the success of the operation itself, chemotherapy is commonly given prior to surgery. IDH-1 targeting drugs were developed to combat cancers with IDH-1 mutations. However, the research group has found that IDH-1 targeting drugs are also effective against cancer cells without the IDH-1 mutation. Ivosidenib is an FDA-approved drug for relapsed/refractory AML that targets IDH-1. This phase I study will establish the safety of ivosidenib in combination with standard of care chemotherapy, FOLFIRINOX, prior to surgery in patients with pancreatic cancer.
Trial Registration: ClinicalTrials.gov Identifier: NCT05209074