This clinical trial is focused on studying a type of cancer called cholangiocarcinoma, which affects the bile ducts. The study is specifically for patients who have locally advanced or metastatic cholangiocarcinoma, meaning the cancer has spread and cannot be removed by surgery. The treatment being tested is a medication called ivosidenib, which is taken as a film-coated tablet. Ivosidenib is designed to target a specific genetic mutation known as IDH1 that is found in some patients with this type of cancer.
The purpose of the study is to evaluate the safety of ivosidenib in patients who have already received other treatments for their cancer. Participants in the study will receive ivosidenib and will be monitored for any side effects or changes in their health. The study will also look at how the cancer responds to the treatment, including how long patients live without the cancer getting worse and their overall survival. Additionally, the study will assess the quality of life of participants using a questionnaire designed for patients with cholangiocarcinoma.
Throughout the study, participants will have regular check-ups, which may include blood tests, heart monitoring with an ECG (a test that records the electrical activity of the heart), and assessments of their general health and well-being. The study aims to provide early access to ivosidenib for patients who have limited treatment options and to gather important information about its effects in this group of patients.
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