Study Condition(s): Biliary Tract Cancer

A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer

Study Alias: JSBF

Study Identifier(s): Tool Tip Icon {{ defaultRegistry.registryAnchorText }} NCT02711553 {{ currentLocaleObject.registryAnchorText }}

Study Purpose

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.

Key Participation Requirements Tool Tip Icon

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

Gender

Male Female

Age

18+ years

Time Commitment

The duration of your participation depends on how well your disease responds to the study treatment.
  • 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

Where to Participate

89 locations are currently available of 100 planned
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