A Phase II, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of TT-00420 Tablet in Adult Patients with Advanced Cholangiocarcinoma

Protocol No
TRANSTHERA-TT420C1206
Principal Investigator
Aditya Shreenivas
Phase
II
Summary
The purpose of this study is to look at: -The effectiveness of TT-00420 administered alone on advanced/metastatic or surgically unresectable cholangiocarcinoma with or without FGFR2 fusions. - The safety and tolerability of TT-00420 administered alone; - The levels of TT-00420 in your blood after single and multiple doses are administered (Pharmacokinetic [PK] testing). PK is analysis of the amount of TT-00420 in your body at various time points after dosing. TT-00420 is an investigational drug, meaning TT-00420 (referred to as the 'Study Drug') has not been approved for sale by the United States (US) Food and Drug Administration (FDA). It is currently being used for research purposes only. 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 cholangiocarcinoma in the future.
Description
Study to Evaluate the Efficacy and Safety of TT-00420 in Cholangiocarcinoma
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL