Active not recruiting

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

I3O-MC-JSBF - ClinicalTrials.gov - NCT02711553

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.
How long will I be in the trial?
The duration of your participation depends on how well your disease responds to the study treatment.
Email
Active not recruiting

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

I3O-MC-JSBF - ClinicalTrials.gov - NCT02711553

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.
How long will I be in the trial?
The duration of your participation depends on how well your disease responds to the study treatment.
Email

Key Requirements

Age :

18+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

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

Trial Summary

Conditions the trial is for

Biliary Tract Cancer

What the trial is testing?

A1: Ramucirumab + cisplatin and gemcitabine, A2: Placebo + cisplatin and gemcitabine, B1: Merestinib + cisplatin and gemcitabine, B2: Placebo + cisplatin and gemcitabine

Could I receive a Placebo?

yes

Enrollment Goal

300

Trial Dates

May 2016 - February 2021

Trial Phase

2

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

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

Trial Summary

Conditions the trial is for

Biliary Tract Cancer

What the trial is testing?

A1: Ramucirumab + cisplatin and gemcitabine, A2: Placebo + cisplatin and gemcitabine, B1: Merestinib + cisplatin and gemcitabine, B2: Placebo + cisplatin and gemcitabine

Could I receive a Placebo?

yes

Enrollment Goal

300

Trial Dates

May 2016 - February 2021

Trial Phase

2

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Trial Locations

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Biliary Tract Cancer Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?