Completed Enrollment

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.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Advanced Solid Tumor
What the trial is testing?
Ramucirumab, cisplatin, gemcitabine, Merestinib
Could I receive a Placebo?
Yes
Enrollment Goal
309
Trial Dates
May 19, 2016 - Dec 2025
How long will I be in the trial?
The duration of your participation depends on how well your disease responds to the study treatment.
Trial Phase
II

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • 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:

  • 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

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