Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Phase I/II, Multicenter, Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin in Combination with Irinotecan in Pretreated Patients with Selected Advanced Solid Tumors

This research is looking at a new combination of two medicines, lurbinectedin and irinotecan, for people who have advanced solid cancers that have already received previous treatments. The study is split into two main parts. First, it will carefully increase the dose of the new combination to find the highest dose that can be given safely without too many serious side effects. This is called the Phase I part. Once the right dose is found, the second part (Phase II) will look at how well this new combination works to treat the cancer and continue to monitor for any side effects. Researchers will also study how the body handles these medicines.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Pharma Mar S.A.

Enrolment target

247

Start

20 Aug 2024

Selected Advanced Solid Tumors

What is this study about?

This study is a clinical trial looking into new ways to treat certain advanced solid cancers. 'Advanced' means the cancer has grown or spread beyond its original site. The study focuses on people who have already had other treatments for their cancer.

The main goal is to test a new combination of two medicines: lurbinectedin and irinotecan. Both of these are types of chemotherapy. Chemotherapy works by killing quickly growing cells, which includes cancer cells. Combining different drugs can sometimes make treatments more effective.

The study has two main steps. The first step, called Phase I, is all about finding the safest dose of the two medicines together. Doctors will start with a small dose and gradually increase it in different groups of patients until they find the dose that is most effective while keeping side effects manageable. Once this 'best' dose is found, the second step, Phase II, will use this dose in more people to see how well the treatment shrinks or controls the cancer, and to continue to monitor for any side effects.

Key takeaways

Tests a new combination of lurbinectedin and irinotecan for advanced cancers.
For patients who have already had other cancer treatments.
First part of the study finds the safest dose, second part checks how well it works.
Open to adults aged 18 and over, both men and women.
Involves regular clinic visits, tests, and close monitoring for side effects.

Who may be eligible?

This study is for adults aged 18 years and older. Both men and women can take part.

To be considered, you must have an advanced solid tumour, which means it's a type of cancer that forms a solid mass and has grown or spread in your body. It's also important that you have already received other treatments for your cancer.

Doctors will look at other specific health information and test results to decide if this study is right for you and if it's safe for you to take part. This will help make sure the study gathers useful information and that participants are as safe as possible.

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 an advanced solid tumour?
Have you already received other treatments for your cancer?
Are you able to attend regular clinic visits?
Are you willing to have tests like blood samples and scans?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the investigational medicines, lurbinectedin and irinotecan, according to a schedule determined by the study team. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health, how your body is handling the medicines (pharmacokinetics), and if the treatment is working.

Before you start, and during the study, you'll need to undergo various assessments, which might include particular scans, blood tests, and physical examinations. You will be closely monitored for any side effects. You can withdraw from the study at any time without giving a reason.

Potential risks and benefits

Participating in a clinical trial like this could offer potential benefits, such as gaining access to a new treatment combination before it's widely available. It also contributes valuable information that may help future patients. However, there are potential risks, as the effects and side effects of this specific drug combination are still being evaluated. All medicines can have side effects, and some can be serious. The study team will carefully monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, should you decide it is no longer right for you.

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
France
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Unverified
Italy

Common questions

What does 'advanced solid tumors' mean?

This refers to cancers that form solid lumps and have grown or spread in the body.

What does 'pretreated patients' mean?

It means the study is for people who have already received other cancer treatments in the past.

What are lurbinectedin and irinotecan?

These are both types of medicines used to treat cancer, often called chemotherapy. This study is looking at them together.

Is this a new treatment?

Yes, this study is testing a new combination of these two drugs. It's not yet a standard treatment.

What is the purpose of 'Phase I' of the study?

Phase I aims to find the safest and most effective dose of the drugs to use.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.