Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A phase 1 study to evaluate the dose, safety and tolerability of a radionuclide therapy (Radspherin®) in patients with platinum sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma with peritoneal carcinomatosis following complete surgical resection

This early-stage study is for women in the UK who have ovarian, fallopian tube, or primary peritoneal cancer that has returned and is sensitive to platinum-based chemotherapy. If their cancer has spread within the tummy area (peritoneal carcinomatosis) and they've had all visible cancer removed by surgery, they might be able to join. The study is testing a new treatment called Radspherin®. It's the very first time this treatment is being given to people, so the main goals are to find a safe dose and see what side effects it might have. This type of research helps doctors understand if a new treatment is safe enough to be studied further in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Oncoinvent ASA

Enrolment target

Start

20 Sep 2024

Platinum Sensitive Recurrent Epithelial Ovarian Fallopian Tube or Primary Peritoneal Carcinoma With Peritoneal Carcinomatosis

What is this study about?

This study is about a new treatment called Radspherin® for women with certain types of cancer that affect the ovaries, fallopian tubes, or the lining of the tummy (peritoneum). Sometimes, even after treatment, these cancers can come back, especially in the tummy area. This study is for women whose cancer has returned but can still be treated with a type of chemotherapy called 'platinum-sensitive'. It's also for those who have had surgery to remove all the cancer they can see.

The main purpose of this study is to find out the best and safest dose of Radspherin®. Because this is the first time it's being given to people, it’s called a 'Phase 1' study. Researchers want to make sure it's safe to use and to understand what effects it has on the body. They will carefully watch for any side effects and learn how the treatment works.

Finding new ways to treat cancer is an ongoing process. Studies like this are a very important first step. If this new treatment is found to be safe, it could potentially help patients with these types of cancer in the future. It helps doctors decide if Radspherin® is worth studying in more detail.

Key takeaways

This is an early-stage UK study for specific ovarian, fallopian tube, or peritoneal cancers.
It's testing a new treatment called Radspherin® for the first time in people.
The main goals are to find a safe dose and understand side effects.
Patients must have had recent surgery to remove all visible cancer and be platinum-sensitive.
Participation helps future cancer research, but direct benefit isn't guaranteed.

Who may be eligible?

This study is for women aged 18 or over. You might be able to join if you have ovarian, fallopian tube, or primary peritoneal cancer that has come back. Importantly, your cancer needs to be 'platinum-sensitive', which means it responded well to platinum-based chemotherapy in the past.

Your cancer also needs to have spread to the lining of your tummy (this is called peritoneal carcinomatosis). You will also need to have recently had surgery where all visible cancer was removed.

There will be other detailed medical checks to make sure the study is right for you and that you are healthy enough to take part. Your doctor can explain these in more detail.

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 a woman aged 18 or older?
Has your ovarian, fallopian tube, or primary peritoneal cancer come back?
Was your cancer sensitive to platinum-based chemotherapy before?
Has your cancer spread to the lining of your tummy?
Have you recently had surgery where all visible cancer was removed?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to the hospital. Initially, you would have screening tests to make sure the study is right for you. If you are eligible, you would receive the study treatment, Radspherin®, and have regular check-ups, scans, and blood tests to monitor your health and how the treatment is working. The study team will carefully explain the schedule of visits and what each involves. You would be followed up for a period after your main treatment to see how you are doing overall. The total duration of your involvement in the study would be explained to you by the study team.

Potential risks and benefits

Patients who join this study might not directly benefit from the new treatment, as the main goal is to test its safety and find the right dose. However, by taking part, you could be helping to find better treatments for women with similar cancers in the future. As with any new treatment, there could be side effects or risks that are not yet known, because it’s the first time it’s being used in people. The study team will explain all known risks. You can choose 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
Norway
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Unverified
Belgium

Common questions

What does 'platinum-sensitive' mean?

It means your cancer responded well to a type of chemotherapy called platinum-based chemotherapy when you had it before.

What is 'peritoneal carcinomatosis'?

This means that your cancer has spread to the lining of your tummy, also known as the peritoneum.

What is Radspherin®?

Radspherin® is the name of the new treatment being tested in this study. It's a type of radiation treatment.

Why is this called a 'Phase 1' study?

A Phase 1 study is the first step where a new treatment is tried in people. The main goals are to check its safety and find the right dose.

Will I get better if I join this study?

While the aim is to find new treatments, the main goal of this early study is to check the safety and dose of Radspherin®. There's no guarantee you will get better, but your participation is very valuable for future patient care.