A Phase III Open-Label, Multi-Centre, Randomised Study Comparing NUC-1031 plus Cisplatin to Gemcitabine plus Cisplatin in Patients with Previously Untreated Locally Advanced or Metastatic Biliary Tract Cancer

The purpose of this study is to test the anti-cancer activity of NUC-1031 when given in combination with Cisplatin, and to compare it with the standard treatment of Gemcitabine in combination with Cisplatin in people with biliary tract cancer. This study will also explore the safety of the study treatments and the impact they have on your quality of life. In a subset of participants, we will also look at how your body breaks down the study drugs. This is known as a pharmacokinetic study. In clinical studies, subjects with cancer (including biliary tract cancer) have already been given NUC-1031 (alone or in combination with Cisplatin). In these clinical studies, NUC 1031 has been well-tolerated. NUC-1031 is still experimental and is not approved by the U.S. Food and Drug Administration (FDA). Cisplatin and Gemcitabine are FDA-approved chemotherapy drugs that are part of standard treatment for many people with biliary tract cancer. We don’t know if this study will help you. Your condition may get better but it could stay the same or even get worse. We hope the information from this study will help us develop a better treatment for biliary tract cancer in the future.