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.
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.
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 - December 2022
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 - December 2022
Trial Phase
2
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