Biliary Tract Cancer
A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer
The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer.
The duration of your participation depends on how well your disease responds to the study treatment.
Key Participation Requirements
All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria
Participants must have a diagnosis of non-resectable, recurrent or metastatic biliary tract confirmed by histology or cytology
Participants must be sterile, postmenopausal or compliant with a highly effective contraceptive method
Female participants of childbearing potential must have a negative pregnancy test prior to starting the study
Participants must be willing to provide blood/serum/plasma and tumor tissue samples for research purpose (unless restricted per local regulations)
Participants must not have had previous systemic therapy for locally advanced or metastatic disease
Participants must not have loss of brain function due to liver disease or ascites of Grade >1, or cirrhosis with Child-Pugh Stage B or higher
Participants must not have ongoing or recent (≤6 months) hepatorenal syndrome
Participants must not have brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression
Participants must not have had a heart attack, unstable angina, stroke, or mini stroke within 6 months prior to entering the study
Participants must not have a previous malignancy within 5 years of study entry or a concurrent malignancy