Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A dose-esalation phase I/II study in patients with RAS-mutated metastatic colorectal cancer to investigate safety and clinical actvitiy of the triple combination of: MEK-inhibitor binimetinib, pan-EGFR inhibitor lapatinib and the microtubule targeting agent (MTA) vinorelbine (RASTRIC)

This research trial is for adults in the UK with advanced bowel cancer that has a specific genetic change called a RAS mutation. This means standard treatments haven't been effective or aren't suitable. The study is testing a new combination of three existing medicines: Mektovi, Tyverb, and Vinorelbine. It's a two-part study. The first part aims to find the safest and most effective dose of this three-drug combination. The second part will then look at how well this chosen dose works to shrink tumours. The overall goal is to understand if this new combination could offer a new treatment option for people with this type of cancer.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Universitair Medisch Centrum Utrecht

Enrolment target

Start

10 Sep 2024

What is this study about?

This study, called RASTRIC, is looking for a new treatment approach for people in the UK who have advanced bowel cancer (also known as colorectal cancer) that has spread to other parts of the body. Importantly, this study is specifically for those whose cancer has a particular genetic change called a RAS mutation. This means that regular treatments like chemotherapy (using medicines such as 5-FU/capecitabine, oxaliplatin, and irinotecan) haven't worked well enough, or these treatments couldn't be given. The researchers want to see if combining three existing medicines – Mektovi, Tyverb, and Vinorelbine – can be a safe and effective way to treat this type of cancer.

The study has two main parts. The first part is about finding the right dose for these three medicines when given together. The researchers will start with a low dose and gradually increase it in different groups of patients until they find the highest dose that can be given safely without causing too many severe side effects. This is really important to make sure the treatment is as safe as possible while still being effective. Once they find this best dose, the second part of the study will begin.

In the second part, more patients will receive this chosen dose. The main goal here is to see how well the combination works to shrink tumours or stop the cancer from growing, as measured by scans. The researchers will also carefully monitor any side effects, how the body handles the medicines, and how long people live without their cancer getting worse. This information will help them understand if this triple combination could be a useful new treatment for people with RAS-mutated advanced bowel cancer that has been difficult to treat.

Key takeaways

This study tests a new combination of three medicines for advanced bowel cancer.
It's for people whose cancer has a 'RAS mutation' and hasn't responded to standard treatments.
The first stage finds the safest dose, and the second stage checks how well it shrinks tumours.
Regular hospital visits, blood tests, and scans are part of participating.
This is a research study; there's no guarantee it will work, but it could offer a new option.
You can stop participating at any time.

Who may be eligible?

This study is designed for adults aged 18 and older with advanced bowel cancer that has spread to other parts of the body. A key requirement is that your cancer must have a specific genetic change called a 'RAS mutation'. Your doctor will be able to tell you if your cancer has this specific change.

Another important point is that you must have already tried standard chemotherapy treatments for advanced bowel cancer, such as those including 5-FU/capecitabine, oxaliplatin, and irinotecan, and these treatments either haven't worked for you, or your doctors decided you couldn't safely receive them. So, this study is generally for people whose cancer has progressed despite previous treatments.

Both men and women can take part in this study, provided they meet all other criteria. Your medical team will carefully review your health and medical history to make sure that taking part in this study is suitable and safe for you.

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.

Are you 18 years old or older?
Do you have advanced bowel cancer that has spread?
Has your doctor confirmed your cancer has a 'RAS mutation'?
Have you already tried standard chemotherapy treatments for your cancer, or couldn't you have them?
Are you able to attend regular hospital appointments for treatment and tests?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be given a combination of three medicines: Mektovi, Tyverb, and Vinorelbine. These will be given at specific times and doses determined by the study. You'll have regular hospital visits for blood tests, scans (like CT scans) to check your tumour size, and physical exams to monitor your health and any side effects. You will also be asked about how you are feeling and any symptoms you might have. The study team will explain the exact schedule of visits and treatments, which can vary depending on which part of the study you are in. The total duration of your participation will depend on how you respond to the treatment, but you will be monitored closely throughout.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. A potential benefit of this study is that the new combination of medicines might help to shrink your cancer or stop it from growing, especially if other treatments haven't worked. However, there's no guarantee this treatment will be effective for you. Potential risks include experiencing side effects from the medicines, which could range from mild to severe. The study team will monitor you very closely for any side effects and will explain them in detail before you start. Remember, this is a research study, and finding what works best is part of the process. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Netherlands

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 help decide the best treatment approach for your type of bowel cancer.

What does 'metastatic' mean?

'Metastatic' means the cancer has spread from where it started (in this case, the bowel) to other parts of your body. This is often called advanced cancer.

Are these new medicines?

The medicines – Mektovi, Tyverb, and Vinorelbine – are not entirely new, but combining them in this specific way for your type of bowel cancer is what's being studied as a new approach.

What are 'Phase I' and 'Phase II' studies?

Phase I is about finding the safest dose and looking at side effects. Phase II then checks how well that safest dose works to treat the cancer in a larger group of people.

Will I know if the treatment is working?

Yes, the study team will regularly perform scans and tests to see how your body is responding to the treatment, and they will share this information with you.