AuthorisedTherapeutic exploratory (Phase II)Interventional

VINORELBINE INHIBITS ONCOGENIC FUNCTIONS OF MKK3: A NEW THERAPEUTIC OPPORTUNITY FOR PATIENTS WITH METASTATIC COLORECTAL CANCER

This research is investigating a medicine called Vinorelbine for people with bowel cancer that has spread to other parts of the body. The main goal is to see how many patients respond to the treatment, meaning their tumours shrink or disappear. This will be checked using CT scans. Researchers also want to understand if Vinorelbine helps people live longer, stops the cancer from growing, and improves their quality of life. The study aims to gather important information about this potential new treatment option for metastatic colorectal cancer.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

I.F.O. Istituti Fisioterapici Ospitalieri

Enrolment target

Start

09 May 2025

METASTATIC COLORECTAL CANCER

What is this study about?

This study is testing a medicine called Vinorelbine as a new treatment for bowel cancer that has spread to other parts of the body, also known as metastatic colorectal cancer. Bowel cancer is cancer that starts in the large bowel (colon or rectum). When it spreads, it's called metastatic.

The researchers want to see if Vinorelbine can help shrink the cancer. They'll measure this by looking at how many patients' tumours get smaller or even disappear after taking the medicine. This is a "Phase II" study, which means it's still in the early stages of testing and aims to find out if the treatment is effective enough to be studied in a larger group of people.

Ultimately, the results of this study could help doctors understand if Vinorelbine is a good option for treating this type of cancer, potentially leading to new ways to help patients in the future.

Key takeaways

This study is for adults with bowel cancer that has spread.
It's testing a medicine called Vinorelbine in capsule form.
The main aim is to see if the cancer shrinks.
CT scans will be used regularly to check progress.
The study also looks at how the treatment affects quality of life and survival.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can take part.

There might be other health conditions or previous treatments that could mean you can't join, even if you meet the age and sex requirements. The study team will check all your medical information carefully to make sure it's safe and right for you to participate.

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 bowel cancer that has spread to other parts of your body?
Are you able to take medicines by mouth?
Are you willing to have regular CT scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given Vinorelbine medicine, which comes in soft capsules. Your doctors would regularly check how you are responding to the treatment. This will mainly involve having CT scans of your chest and tummy every 8 weeks (about every two months) to see if your tumours have shrunk. The study will also track how long the cancer stays stable, how long patients live, and if you experience any side effects. You'll also be asked about your quality of life. The total duration of your participation would depend on how your cancer responds to the treatment and your overall health.

Potential risks and benefits

Potential benefits of joining could include receiving a new treatment that might help shrink your cancer or slow its growth. However, there's no guarantee it will work for everyone. As with any medicine, there are potential risks, and you might experience side effects from the Vinorelbine. The study team will monitor you closely for any side effects and will tell you about them before you decide to join. Remember, taking part in any clinical trial is completely voluntary, and you have the right to withdraw at any time without it affecting your 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
Italy

Common questions

What is metastatic colorectal cancer?

It's when bowel cancer has spread from where it started to other parts of your body.

What is Vinorelbine?

It's a medicine being tested in this study to see if it can treat metastatic colorectal cancer.

What does 'tumour shrinkage' mean?

It means the cancer growth gets smaller in size, which is a good sign the treatment is working.

How often will I have scans?

You'll have CT scans of your chest and tummy every 8 weeks to check on your cancer.

Will I know if the treatment is working?

Yes, the doctors will tell you the results of your scans and how your cancer is responding.