A trial of telotristat etiprate for people who have symptoms of carcinoid syndrome that are not controlled with other drugs (TELESTAR)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Carcinoid
Neuroendocrine tumour (NET)

Status:

Closed

Phase:

Phase 3

This trial is looking at a new drug called telotristat etiprate (also known as LX1606) for people who have symptoms of carcinoid syndrome that are not controlled with other drugs.

Neuroendocrine tumours (NETs) are a rare group of cancers that make and release hormones Open a glossary item. They are normally found in the digestive system Open a glossary item. The most common type of NET is a carcinoid tumour.

A carcinoid tumour can produce a substance called serotonin which causes symptoms such as diarrhoea, frequent bowel movements, tummy (abdominal) pain and redness of the face (flushing). This is known as carcinoid syndrome.

Doctors may treat carcinoid syndrome with drugs called somatostatin analogues. These drugs can help, but after a while, they may stop working. Researchers are looking for new treatments to help people in this situation. In this trial, they are looking at a drug called telotristat etiprate which reduces the production of serotonin.

The aims of this trial are to

  • See if different doses of telotristat etiprate can help to relieve symptoms of carcinoid syndrome when other drugs no longer control them
  • Learn more about the side effects

Who can enter

You may be able to enter this trial if you

  • Have a neuroendocrine tumour that has spread from where it first started and can be measured on a CT scan or MRI scan
  • Have carcinoid syndrome which includes having 4 or more bowel movements on average each day
  • Have been on a stable dose of a somatostatin analogue drug for at least 3 months
  • Have satisfactory blood test results
  • Are at least 18 years old
  • Are willing to use reliable contraception during the trial and for 3 months afterwards if there is any chance you or your partner could become pregnant

You cannot enter this trial if you

  • Have diarrhoea for any reason other than carcinoid syndrome
  • Have watery diarrhoea more than 12 times a day that is causing problems such as dehydration or low blood pressure – the trial doctor can advise you about this
  • Have an infection in your bowel – the trial team will test a stool sample to check for this
  • Need help to care for yourself (you have a Karnofsky performance status of 60% or less)
  • Have had any treatment aiming to reduce the size of your tumour in the last 4 weeks
  • Have had major surgery in the last 8 weeks
  • Have had surgery to remove some of your small bowel, or have ever had a medical condition that affects how you absorb nutrients from food (short bowel syndrome)
  • Have already had LX1606 (telotristat etiprate)
  • Have had another experimental drug in the last month or treatment with an antibody in the last 3 months
  • Have certain heart problems – the trial team can advise you about this
  • Have abused drugs or alcohol in the last 2 years
  • Have any other medical condition or test result that the trial team think could make it unsafe for you to take part
  • Are pregnant or breastfeeding

Trial design

This phase 3 trial will recruit about 120 people. 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. This is called a double blind trial.

In this trial there are 3 treatment groups

  • A lower dose of telotristat etiprate
  • A higher dose of telotristat etiprate
  • A dummy drug (placebo Open a glossary item)

Whichever group you are in, you take 2 tablets, 3 times a day. After 12 weeks of treatment, everybody can start having the higher dose of telotristat etiprate. This is called the extension period of the trial and lasts for about 9 months (36 weeks).

TELESTAR & TELECAST trial diagram

Before you start taking the tablets, the trial team want to gather information about any symptoms you have. They will do this for up to 4 weeks. This is called the run-in period.

If you are taking a somatostatin analogue when you join the trial, your doctors can’t change the dose during the run-in period or during the first 12 weeks of treatment. If you aren’t taking a somatostatin analogue when you join the trial, you can’t start taking one during the run-in period or during the first 12 weeks of treatment.

The trial team will give you an electric diary which is like a mobile phone. You use this to keep track of how you feel and how many bowel movements you have each day. You start keeping the diary at least 3 weeks before you start the tablets. And you must use it every day throughout the trial.

The researchers will ask your permission to take an extra blood sample to study your DNA to learn more about how genes affects peoples’ responses to telotristat etiprate. And they will ask you to give some extra blood samples that they can use to learn more about what happens to the drug in your body. This is called pharmacokinetics Open a glossary item. You don’t have to give the extra samples for either of these research studies if you don’t want to. You can still take part in the main trial.

The trial team will also ask you to have an interview with a researcher at the end of the first 12 weeks of treatment (or when you finish treatment if you stop taking the tablets before the end of 12 weeks). If you agree to do this, they will ask you about your experience of having carcinoid syndrome, and the impact the symptoms have on your everyday life. They will also ask if you’ve noticed any improvement in your symptoms during the trial.

The researcher will make an audio recording of the interview, but all the information you provide is confidential Open a glossary item.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

  • Physical examination
  • Heart trace (ECG Open a glossary item)
  • Blood tests
  • Urine test and stool test

During the first 12 weeks of treatment, you see the trial team up to 4 times. At these visits you have a physical examination, blood tests and urine tests. You may also have an ECG. And the trial team may ask you to collect all the urine you pass in a 24 hour period.

During the 9 months of the extension period, you see the trial team 8 times. At each visit you have a physical examination, blood tests and urine tests. You may have more ECGs.

When you finish treatment, you see the trial team again 2 weeks later. They will ask you to collect all the urine you pass in a 24 hour period. You also have more blood tests and you may have an ECG.

Side effects

As telotristat etiprate is a new drug, there may be side effects we don’t know about yet. In earlier trials looking at this drug for carcinoid syndrome, the most common side effects have been

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Martyn Caplin

Supported by

Experimental Cancer Medicine Centre (ECMC)
Lexicon Pharmaceuticals
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 11228

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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