A trial looking at LY2495655 to treat muscle loss and weakness in people with advanced pancreatic cancer (JDDG)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at a new drug called LY2495655 to treat muscle loss and weakness in people with pancreatic cancer that has spread into nearby tissue (
) or to another part of the body.
People with advanced cancer often have loss of muscle and muscle weakness. Currently there is no treatment for this. This trial is looking at a drug called LY2495655 to help stop muscle loss and weakness.
LY2495655 works by blocking a substance (protein) called myostatin. Myostatin controls muscle growth in the body. By blocking it, the researchers hope LY2495655 will help control muscle loss and weakness.
The researchers will be looking at LY2495655 in combination with chemotherapy for advanced pancreatic cancer. The trial drug will not be treating the cancer itself.
The aims of this trial are to find out
- How safe LY2495655 is
- What are the side effects are when you have it with chemotherapy
Who can enter
You may be able to enter this trial if you
- Have pancreatic cancer that has started to grow into the nearby tissue or blood vessels (stage 2 or 3) or has spread to another part of the body (stage 4)
- Have satisfactory blood test results
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are willing to use reliable contraception during treatment and for 3 months afterwards if you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if
- You have a type of pancreatic cancer called an endocrine tumour or cancer where the pancreatic duct meets the bile duct (ampullary cancer)
- Your pancreatic cancer can be removed with surgery
- Your cancer has spread to your brain or spine
- You can have radiotherapy with the aim of curing your cancer
- You have already had chemotherapy for advanced cancer - you may be able to take part if you had chemotherapy after surgery to try to stop the cancer coming back
- You have had LY2495655 or a similar drug before
- You are having gemcitabine combined with another drug apart from erlotinib
- You are allergic to gemcitabine, LY2495655, drugs called monoclonal antibodies or any of their ingredients
- You have had an experimental drug or used an experimental device as part of a clinical trial in the past month
- You still have side effects from any previous treatment
- You have a muscle disease, for example polymyositis or rhabdomyolysis
- You have an abnormal collection of fluid around your abdomen (
ascites ) or between the sheets of skin which cover the lungs (pleural effusion ) that needs to be drained regularly to relieve symptoms - You have broken any bones in the past 6 months
- You have had a stroke or an injury to your spinal cord in the past 6 months
- You have an infection
- You have another cancer that could affect you taking part in this trial
- You have HIV, hepatitis B or hepatitis C and your infection is causing problems
- You are taking muscle building or performance enhancing drugs, for example
androgen therapies or anabolic steroids
Trial design
This is a phase 2 trial. It will recruit 120 people from different countries around the world. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in either. This is called a double blind trial.
The 2 groups are
- LY2495655 with chemotherapy
- Dummy drug (placebo) with chemotherapy
Your doctor will talk to you about which chemotherapy is best for you and how you have it.
You have LY2495655 or the dummy drug as an injection into a vein. You have LY2495655 or the dummy drug every 2 weeks while you continue to have your chemotherapy. As long as you don’t have bad side effects, you can carry on having LY2495655 for as long as it helps you, even if you stop your chemotherapy.
The trial team will ask you to fill out a questionnaire before you start treatment, during your treatment and then after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
The researchers will also take a blood sample to find out how LY2495655 works in your body and how your genes may affect the way you respond to it and the side effects you may have. You must agree to this if you want to take part in this trial.
Hospital visits
You see the doctor to have some tests before taking part in the trial. These tests include
- A physical examination
DEXA scan - CT scan
Breathing tests - Blood tests
- Urine test
- Measuring how far you can walk and your overall strength
During treatment you see the doctor regularly for the same tests. You have LY2495655 or the dummy drug every 2 weeks.
Your doctor will talk to you about when they want to see you after you finish treatment.
Side effects
LY2495655 is a new drug and there may side effects we don’t know about. The known side effects include
- A reaction at the site of the injection
- Headache
- Tiredness (fatigue)
- Muscle twitching
- Pain
- Stomach problems such as pain, upset tummy or feeling sick (nausea)
- Diarrhoea
- Taste changes and decreased appetite
- Wind
Your doctor will talk to you about the possible side effects of LY2495655 and the chemotherapy you have before you agree to take part in this trial.
We have more information about chemotherapy for advanced pancreatic cancer and the side effects of treatment on our chemotherapy for pancreatic cancer page.
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Professor Kenneth Fearon
Supported by
Eli Lilly and Company Limited
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
