Protocol No
NUCANA-NUTIDE-121
Principal Investigator
Aditya Shreenivas
Phase
III
Summary
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.
Description
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.
combination with Cisplatin, and to compare it with the standard treatment of Gemcitabine in
combination with Cisplatin in people with biliary tract cancer.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
Sub Category
ClinicalTrials.gov