Badanie nad ivosidenibem u pacjentów z wcześniej leczonym miejscowo zaawansowanym lub przerzutowym cholangiocarcinoma

Cholangiocarcinoma is a type of cancer that affects the bile ducts, which are tubes that carry bile from the liver to the small intestine. This study focuses on patients with locally advanced or metastatic cholangiocarcinoma, meaning the cancer has spread beyond its original location and cannot be removed by surgery. The study is investigating the safety of a drug called ivosidenib, which is taken as a film-coated tablet. Ivosidenib is designed to target specific genetic changes in the cancer cells.

The purpose of the study is to understand how safe ivosidenib is for patients who have already received other treatments for their cancer. Participants in the study will take ivosidenib and be monitored for any side effects or changes in their health. The study will also look at how the cancer responds to the treatment, how long patients live without the cancer getting worse, and the overall survival of the patients. Additionally, the study will assess the quality of life of the participants using questionnaires.

The study is open-label, meaning both the researchers and participants know what treatment is being given. It is a phase 3b study, which means it is conducted after initial studies have shown that the drug is safe and may be effective. The study will not use a placebo, and all participants will receive ivosidenib. The treatment period can last up to 24 months, depending on the patient's response and tolerance to the medication.