A phase 2 trial looking at a new drug called entrectinib for treating locally advanced and advanced tumours with certain genetic faults
Full title: Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients with Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) (STARTRK-2)
Why is this trial being carried out?
The cells that make up our body are controlled by genes. Genes give instructions to our cells to tell them to grow and divide to keep our body working properly. Sometimes these genes are faulty. This fault can be inherited from our parents, or the fault may be a random mistake that is made when a cell divides. Genetic faults are sometimes called mutations.
This phase 2 clinical trial is for people with locally advanced and advanced (or metastatic) pancreatic cancer (as well as other cancers), that have a fault in the following genes;
- NTRK 1/2/3
- or ALK.
Locally advanced pancreatic cancer is cancer that has started growing into the organs or large blood vessels surrounding the pancreas and can’t be removed with surgery. Advanced pancreatic cancer is cancer that has spread to other parts of the body away from the pancreas.
Researchers on the STARTRK-2 trial are looking at a new type of cancer drug called entrectinib. Entrectinib may help to stop cancer cells from growing. It works by targeting the faulty genes and stopping the changes that cause cells to grow too quickly and in an uncontrolled way.
Earlier research into other types of cancer showed that entrecitinib helped to slow down the development of cancer in a small number of people with faults in these genes. Researchers now want to test the drug on a larger group of people.
The STARTRK-2 trial will aim to find out how safe entrecitinib is, how well it works and learn more about any side effects.
You will need to have a tissue sample (a biopsy) taken from your tumour to test if you have faults in the NTRK1/2/3, ROSI or ALK genes. This is to check that you are suitable to take part in this trial. Researchers may be able to test a sample that was already taken at an earlier stage if you have had a biopsy or surgery. You will also have a blood test.
If you are suitable to take part in this trial you will need to have the following tests before you start the treatment:
- a physical examination
- an ECG (electrocardiogram) to check if you have any problems with your heart
- an MRI (magnetic resonance imaging) scan
- and a CT (computerised tomography) scan of your brain, chest and abdomen (tummy).
People taking part in the STARTRK-2 trial will take an entrectinib capsule once a day for as long as the treatment is helping. This depends on how well you are feeling and how you are coping with any side effects.
Your first dose of entrectinib will need to be taken in hospital, but you should be able to take the capsules at home afterwards. You will need to visit the hospital for a check-up and blood tests twice a month for three months, and once a month after that. You will also have an MRI or CT scan once a month for two months, and every two months after that.
Who is the trial suitable for?
The STARTRK-2 trial may be suitable for you if:
- you have a locally advanced or advanced cancer with a gene fault in the NTRK 1/2/3, ROSI or ALK genes
- any chemotherapy or radiotherapy you have had finished at least two weeks before starting the trial
- you are well enough to be up and about for at least half the day
- you are able to swallow the entrectinib capsule whole without crushing it
- you have satisfactory blood tests – the trial team will discuss this with you.
It may not be suitable for you if:
- you are taking part in another clinical trial
- your cancer has spread to your brain or the area surrounding your brain, unless you have had treatment for this, and/or cancer isn’t causing any symptoms
- you have already had treatment that works like entrectinib in targeting the same faulty genes – your medical team can discuss this with you
- you have had other cancers in the past that might affect how well entrectinib works
- you have not fully recovered from any surgery
- you are taking steroids and the dose of steroids has not stayed the same or decreased for at least two weeks before starting this trial
- you have peripheral neuropathy, which causes numbness or tingling in your hands or feet
- you have problems with your heart, have a history of abnormal heart rhythm or have certain heart conditions – you medical team can explain this more
- you have an infection that might affect how well entrectinib works
- you have any digestive problems, such as Crohn’s disease, which might affect how well you absorb entrectinib. People with pancreatic cancer who have diet problems managed by pancreatic enzyme supplements such as Creon® or Pancrease® can take part in this study – your medical team can discuss this with you
- you have a type of lung disease called interstitial lung disease, or you have inflammation of the lungs.
There may be other reasons for not being able to take part in a trial. It is important to speak to your medical team about whether this trial might be suitable for you.
Recruitment start date: March 2016
Recruitment end date: December 2018
Published July 2018
Review date July 2021
The STARTRK-2 trial is being carried out in:
- Addenbrookes Hospital, Cambridge
- Sarah Cannon Research Institute, London
- The Christie NHS Foundation Trust, Manchester
Dr Simon Pacey
You can contact the trial centres by emailing STARTRKtrials@ignyta.com
How to join a trial
Please speak to your consultant about whether this trial is suitable for you.
If you have any questions about pancreatic cancer you can speak to one of our specialist nurses on our Support Line.
How to find out more
For further information about this trial please visit the ClinicalTrials.gov website.
For references used to develop this information please email us.