Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A study to compare Onivyde manufactured at two different production sites in adult participants with advanced cancer in the pancreas

This study is for adults with advanced pancreatic cancer, which has spread to other parts of the body. The research team is looking at a specific cancer medicine called Onivyde. Medicines like Onivyde are often made in different places, and it's important to make sure they all work in the same way in the body. This study wants to confirm that Onivyde produced at two separate manufacturing sites is equally effective and safe. It's an early-stage study, meaning researchers are mainly focused on understanding how the medicine behaves in people. This type of research helps ensure that patients always receive consistent, high-quality treatment, no matter where their medication is made.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Ipsen Pharma

Enrolment target

120

Start

14 Oct 2024

Metastatic Pancreatic Adenocarcinoma

What is this study about?

This study is for people in the UK who have advanced pancreatic cancer. Advanced cancer means it has spread from where it started. The main goal of this research is to compare a cancer medicine called Onivyde that has been made in two different places or factories. Think of it like buying your favourite brand of crisps; they might be made in two different factories, and you'd expect them to taste and be exactly the same. In the same way, when a medicine is made at different sites, it's really important to check that it is absorbed, used, and processed by the body in exactly the same way.

This is called a 'bioequivalence' study, which is a scientific way of saying researchers want to confirm that the medicine from both factories has the same effect in your body. It's a very early stage of research, known as a Phase I study. This means the main focus is on understanding how the medicine acts in people, rather than its full effects on the cancer itself. These studies are crucial for making sure that all batches of a medicine, regardless of where they are made, are consistent and safe for patients.

By taking part, you would be helping researchers ensure that patients battling advanced pancreatic cancer receive reliably manufactured medicine. Your participation helps guarantee that Onivyde, a treatment used for this condition, remains consistent and trustworthy, which is vital for effective cancer care.

Key takeaways

This study compares two versions of the cancer medicine Onivyde.
It's for adults with advanced pancreatic cancer.
The goal is to ensure the medicine works the same, no matter where it's made.
Participation helps guarantee consistent quality of cancer treatment.
It's an early-stage study focusing on how the medicine behaves in the body.
Patients can withdraw at any time without affecting their regular care.

Who may be eligible?

This study is for adults aged 18 or older. It is open to both men and women. The main requirement for joining is that you have advanced pancreatic cancer that has spread to other parts of your body. The medical term for this type of cancer is 'metastatic pancreatic adenocarcinoma'.

There will be other detailed rules about who can and cannot join, which a study doctor will explain to you. For example, they will look at your overall health, other medicines you might be taking, and any other medical conditions you have. These rules are in place to make sure the study is safe for you and that the results are clear and accurate.

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 pancreatic cancer that has spread to other parts of your body?
Are you able to attend regular appointments for medical checks and tests?
Are you willing to take the study medicine, Onivyde, as directed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, Onivyde. The study team would closely monitor you. This would involve regular visits to the hospital or clinic, where you might have blood tests, physical examinations, and other checks to see how your body is responding to the medicine and if you're experiencing any side effects. You would be given the medicine and observed over a period to understand how it behaves in your body.

The research team will explain the full schedule of visits, tests, and how long your participation would last. You won't be on the study medication for an extended period, as the main goal is to compare how quickly the different versions of Onivyde are absorbed and leave your body. You'll have follow-up appointments to ensure everything is well after completing the study treatment.

Potential risks and benefits

The main benefit of taking part in this study is contributing to medical knowledge that ensures the quality and consistency of an important cancer treatment. While this study is not designed to directly treat your cancer, your involvement helps ensure that future patients receive safe and effective medicine. As with any medicine, there are potential risks and side effects from Onivyde, which the study team will explain in detail. They will closely monitor you to manage any side effects. If you join, you are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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
Hungary
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Unverified
Italy
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Unverified
France

Common questions

What is Onivyde?

Onivyde is a medicine used to treat advanced pancreatic cancer.

Why are you comparing medicines from different factories?

We want to make sure that Onivyde made in different places works in exactly the same way in your body.

What kind of cancer is this study for?

This study is for adults with advanced pancreatic cancer that has spread to other parts of the body.

Will this study cure my cancer?

This study is focused on how the medicine works in the body, not primarily on curing cancer. Your participation helps ensure consistent quality of treatment for all patients.

Can I stop being in the study?

Yes, you can leave the study at any time, for any reason, without it affecting your medical care.