Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomized Phase 2 Study of ompenaclid versus placebo in combination with FOLFIRI plus bevacizumab in patients with previously treated RAS mutant advanced or metastatic colorectal cancer

Doctors are conducting a study to find better ways to treat advanced bowel cancer, particularly in people whose cancer has a specific genetic change called a RAS mutation and hasn't responded well to previous treatments. This study is testing a new medicine called ompenaclid. Participants will receive a standard chemotherapy combination (FOLFIRI) plus another drug called bevacizumab. Half of the participants will also receive ompenaclid, while the other half will receive a dummy pill (placebo). The main goal is to see if adding ompenaclid helps shrink the tumours. Researchers will also look at how long people live, how long their cancer is kept under control, and any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Inspirna Inc., Inspirna Inc.

Enrolment target

Start

27 Jul 2023

such as those associated with RAS mutations.

What is this study about?

This study is about finding new and better ways to treat advanced bowel cancer. Bowel cancer that has spread to other parts of the body (called metastatic) and has a particular genetic change, known as a RAS mutation, can be challenging to treat. Scientists are always working hard to discover new medicines that work differently from the ones we already have, especially for specific types of cancer like this.

In this study, doctors are looking at a new medicine called ompenaclid. It's being tested alongside a standard treatment which includes a chemotherapy combination called FOLFIRI and another drug called bevacizumab. Participants will be split into two groups: one group will get ompenaclid with their standard treatment, and the other group will get a dummy pill (called a placebo) with their standard treatment. This allows doctors to fairly compare the new medicine's effects.

The main aim of the study is to see if adding ompenaclid helps to shrink tumours (this is called the overall response rate). They will also be looking at how long people stay well without their cancer getting worse, how long people live in total, how long the treatment effect lasts, and how well the cancer is kept under control. The study will also carefully monitor any side effects people might experience.

Key takeaways

This study is for advanced bowel cancer with a specific 'RAS mutation'.
It tests a new medicine called ompenaclid alongside standard chemotherapy.
Half of the participants get ompenaclid, the other half get a dummy pill (placebo).
Main goal is to see if ompenaclid helps shrink tumours and control cancer.
Regular hospital visits and careful monitoring of your health and any side effects are part of participation.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

Your bowel cancer must be advanced or have spread to other parts of your body. Also, crucial for this study, your cancer needs to have a specific genetic change known as a RAS mutation. This means your doctors would need to have tested your cancer for this mutation.

Finally, the study is for people whose cancer has already been treated with standard methods, but those treatments haven't worked as well as hoped, or the cancer has continued to grow.

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 old or older.
I have advanced bowel cancer or bowel cancer that has spread.
My cancer has been tested and has a 'RAS mutation'.
My cancer has been treated before, but those treatments haven't fully worked.
I am generally well enough to take part in a study like this.

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive FOLFIRI chemotherapy and bevacizumab as part of your standard treatment. On top of this, you will either receive the new medicine, ompenaclid, or a dummy pill (placebo). The dummy pills look just like the ompenaclid tablets and are taken by mouth.

You would have regular visits to the clinic for assessments. These will include physical examinations, blood tests, heart checks (ECGs), and checks of your vital signs like blood pressure. Doctors will also monitor how you are feeling and any side effects you might have. Scans will be used to see if your tumour is shrinking or stable. You would continue treatment for as long as it is helping you and is safe. The total duration of your participation would depend on how your cancer responds to treatment and your overall health, with follow-up appointments continuing even after treatment stops.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. While there's no guarantee, a potential benefit of this study could be that the new medicine, ompenaclid, might help to shrink your tumour or control your cancer for longer than the standard treatment alone. However, like all medicines, ompenaclid can have side effects, which would be monitored very carefully by the study team. You would be fully informed about these possible side effects before deciding to join. Importantly, you are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Belgium
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Unverified
France

Common questions

What is a 'RAS mutation'?

A RAS mutation is a specific change in the genes within your cancer cells. Doctors test for this to understand which treatments might work best for you.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the actual study medicine but doesn't contain any active drug. It helps doctors fairly compare the effects of the new medicine.

How often would I need to visit the hospital?

You would have regular visits for your treatment and check-ups. The exact schedule would be explained to you in detail by the study team.

Will I know if I'm getting the new drug or the placebo?

No, in this type of study, neither you nor your doctors will know whether you are receiving ompenaclid or the placebo. This helps prevent bias in the results.

What does 'advanced or metastatic colorectal cancer' mean?

It means your bowel cancer has spread beyond its original location to other parts of your body, sometimes to organs like the liver or lungs.