Phase I/II study with galunisertib combined with capecitabine in patients with advanced chemotherapy resistant colorectal cancer with peritoneal metastases
This clinical trial is exploring a new treatment option for people with advanced bowel (colorectal) cancer. It focuses specifically on cancer that has spread to the peritoneum—the thin layer of tissue lining the inside of the abdomen—and has stopped responding to standard chemotherapy. Participants will take two medicines together: an experimental tablet called galunisertib and a standard chemotherapy tablet called capecitabine. The trial has two main stages. The first stage looks at safety to discover the best and safest dose of galunisertib to give alongside capecitabine. The second stage examines how well the combination works at shrinking or controlling tumours, and checks how long the benefits last. The goal is to provide a much-needed new treatment choice for patients whose previous treatments have stopped working.
At a glance
What is this study about?
Bowel cancer is one of the most common cancers in the UK. In some cases, cancer cells spread to the peritoneum, which is the smooth layer of tissue lining the inside of the abdomen and wrapping around the tummy organs. When cancer reaches this area and stops responding to standard chemotherapy drugs, finding effective new treatments can be challenging.
This trial is investigating a new treatment approach using two medicines taken by mouth. The first is an experimental drug called galunisertib, which works by blocking specific signals that cancer cells use to grow and protect themselves. The second is capecitabine, a well-established chemotherapy tablet that stops cancer cells from multiplying. Researchers hope that pairing these two medicines together will make them more effective than standard treatment alone.
The study is divided into two linked phases. In Phase I, doctors will closely monitor a small group of patients to find the safest dose of galunisertib when combined with capecitabine, ensuring any side effects are manageable. In Phase II, the trial will test this chosen dose in more people to see how effectively the combination shrinks tumours, halts cancer growth, and supports overall survival.
By taking part, patients help doctors understand whether this combination could become a valuable new treatment for people dealing with advanced bowel cancer that has resisted other therapies.
Key takeaways
- Tests a new combination of two oral drugs: galunisertib and capecitabine.
- Aimed at adults with advanced bowel cancer that has spread to the abdomen lining.
- Specifically designed for cancer that has stopped responding to standard chemotherapy.
- Both study treatments are taken as tablets at home.
- Focuses first on finding a safe dose, then on checking tumour shrinkage and control.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with advanced colorectal (bowel) cancer that has spread to the peritoneum (the lining of the abdomen).
To be considered, your cancer must be resistant to standard chemotherapy, meaning previous treatments have either stopped working or the cancer has continued to grow despite treatment.
Before you can join, the study doctors will check your general fitness and perform tests on your blood, heart, liver, and kidneys to make sure it is completely safe for you to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am 18 years of age or older.
- I have been diagnosed with advanced bowel (colorectal) cancer.
- My cancer has spread to the peritoneum (the lining of the tummy).
- My cancer has stopped responding to standard chemotherapy treatments.
- I am able to swallow tablets.
What does participation involve?
If you join this study, you will take both galunisertib and capecitabine as tablets by mouth at home according to a regular schedule. You will need to make regular visits to the hospital clinic for routine health checks, blood tests, and imaging scans (such as CT scans) so the doctors can see how the cancer is responding. The team will also take blood samples at set times to measure how the medicine is absorbed and processed in your body. You will stay on the study treatment for as long as it remains safe and helps control your cancer. After your treatment ends, the medical team will continue to check in on your health during follow-up visits.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is the main goal of this clinical trial?
The study aims to find the safest dose of the new drug galunisertib when given with capecitabine chemotherapy tablets, and to see how well this combination works against resistant bowel cancer.
How will I take the study medicines?
Both galunisertib and capecitabine are tablets that you swallow with water at home, following clear instructions from your hospital team.
Do I have to pay to take part in this trial?
No. The trial medicines and any extra study tests are provided free of charge, as is standard in UK clinical research.
What happens if the side effects become too difficult?
You should tell your study team straight away. They can prescribe supportive treatments, lower your dose, or pause the study medicine to help you feel better.
Can I leave the trial if I change my mind?
Yes. You have the right to withdraw from the study at any point. Your decision will never affect the standard medical care you receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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