Active not recruitingPHASE2INTERVENTIONAL

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

This research study is for people in the UK who have advanced or metastatic biliary tract cancer. This means the cancer has spread or is difficult to remove. The study is testing two new medications, ramucirumab and merestinib, to see how effective and safe they are when given alongside the usual chemotherapy drugs, cisplatin and gemcitabine. Some participants will receive a dummy drug (placebo) with their chemotherapy. The main goal is to find out if these new combinations can help improve treatment outcomes for this type of cancer. It's a 'Phase 2' study, which means it builds on earlier research and aims to get a clearer idea of the drugs' effects.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Eli Lilly and Company

Enrolment target

309

Start

19 May 2016

Estimated completion

01 Dec 2026

Biliary Tract Cancer Metastatic Cancer Advanced Cancer

What is this study about?

This study is designed for individuals in the UK diagnosed with advanced or metastatic biliary tract cancer. Biliary tract cancer can start in different parts of the bile ducts, including inside or outside the liver, the gallbladder, or a specific area called the Ampulla of Vater. When doctors say a cancer is 'advanced' or 'metastatic', it generally means it has grown or spread to other parts of the body, making it harder to treat with surgery alone. In this situation, chemotherapy is often used to help manage the cancer.

The main purpose of this study is to investigate whether adding new drugs, called ramucirumab or merestinib, to the standard chemotherapy treatment (cisplatin and gemcitabine) can be more effective. Researchers want to understand if these new combinations can shrink the cancer, slow its growth, and improve the overall health of patients. They also want to carefully monitor any side effects to make sure the treatments are safe.

Some participants in the study will receive ramucirumab with their chemotherapy, others will receive merestinib with their chemotherapy, and some will receive a 'placebo' (a dummy drug with no active ingredients) with their chemotherapy. This allows researchers to compare the new drugs against the standard treatment to see if they offer a real benefit. Your doctor will discuss which treatment you might receive if you join the study.

Key takeaways

This study is for people with advanced or metastatic biliary tract cancer.
It tests new drugs (ramucirumab or merestinib) alongside standard chemotherapy.
The aim is to see if these new combinations are effective and safe.
You might receive one of the new drugs or a placebo (dummy drug) with chemotherapy.
Participation involves regular hospital visits, tests, and providing samples.

Who may be eligible?

This study is open to both men and women aged 18 or over. To join, you must have been diagnosed with advanced or metastatic biliary tract cancer that has been confirmed by a doctor, and it must be a type of cancer that can be measured and tracked, for example, on scans. You'll need to be well enough to take part in a study like this, meaning you can carry out most of your daily activities without much difficulty.

There are also some things that would mean you couldn't join the study. For example, if you've had chemotherapy for your advanced biliary tract cancer before, or if you have certain other serious medical conditions affecting your liver, kidneys, or heart. If you've had a recent major surgery or have uncontrolled high blood pressure, you might not be able to participate. Also, if the cancer has spread to your brain or spinal cord, you would not be eligible.

All women who could become pregnant would need to have a negative pregnancy test and agree to use effective birth control during the study. Men also need to agree to use effective birth control if their partner could become pregnant. You would also need to be willing to provide blood and tissue samples, as this is an important part of understanding the effects of the treatment.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with advanced or metastatic biliary tract cancer?
Are you generally well enough to go about your daily life without much help?
Have you not had chemotherapy for your advanced biliary tract cancer before?
Do you have good overall health of your major organs (like liver, kidneys, heart)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will receive one of the study treatments (ramucirumab, merestinib, or a placebo) along with chemotherapy (cisplatin and gemcitabine). These treatments will be given over a period of time, and you'll have regular visits to the hospital or clinic. During these visits, the study team will carry out physical examinations, blood tests, and scans to check how you are responding to the treatment and to monitor for any side effects. You will also be asked to provide blood and tissue samples for research purposes at different times throughout the study.

The frequency of visits and tests will vary, but typically, they are more frequent at the beginning of the study. After your treatment phase is complete, there will be follow-up appointments to continue monitoring your health. The total duration of your participation, including follow-up, could be many months, but the specific length will be discussed with you by the study team. You always have the right to withdraw from the study at any time.

Potential risks and benefits

Taking part in a clinical study means you might receive a new treatment that could potentially help your condition more than standard care, though this is not guaranteed. However, like all medications, the study drugs and standard chemotherapy can have side effects, which could be mild, severe, or even life-threatening. The study team will carefully monitor you for any side effects and will explain all known risks before you make a decision. You will receive detailed information about the potential benefits and risks before you agree to participate, and you are free to leave the study at any time without explaining why, and your medical care will not be affected.

Locations (82)

The University of Arizona Cancer Center
Tucson, United States
UCSF Medical Center at Mission Bay
San Francisco, United States
Georgetown University Medical Center
Washington D.C., United States
University of Florida School of Medicine
Gainesville, United States
Karmanos Cancer Institute
Detroit, United States
Washington University Medical School
City of Saint Peters, United States
Washington University Medical School
Creve Coeur, United States
Washington University Medical School
St Louis, United States
Washington University Medical School
St Louis, United States
Thomas Jefferson University
Philadelphia, United States
Fox Chase Cancer Center
Philadelphia, United States
Florida Cancer Specialists
Nashville, United States

+70 more sites — see the official record for the full list.

Common questions

What is biliary tract cancer?

It's a type of cancer that starts in the bile ducts, which are tubes that carry digestive fluid (bile) from the liver and gallbladder to the small intestine.

What does 'advanced' or 'metastatic' mean?

It means the cancer has either grown significantly within the bile ducts or has spread to other parts of your body.

What are ramucirumab and merestinib?

These are investigational drugs, meaning they are still being studied. They aim to target specific ways cancer cells grow, but they are not yet standard treatments for this cancer.

Will I definitely get one of the new drugs?

Not necessarily. Some participants will receive one of the new drugs with chemotherapy, while others will receive a dummy drug (placebo) with chemotherapy, to help researchers compare the effects.

How long will I be in the study?

The time you spend in the study, including treatment and follow-up, will be discussed with you, but it typically lasts for several months.