Not yet recruitingPHASE1INTERVENTIONAL

Human ADME Study of [14C]-Ceralasertib (AZD6738) and Absolute Bioavailability of Ceralasertib

This study is investigating a new cancer drug called ceralasertib, which might help people with specific types of lung (NSCLC), ovarian, or endometrial cancer. The main goal is to understand how the body takes in, uses, and gets rid of the drug. Researchers will also look at how much of the drug gets into the bloodstream and how long it stays there. Participants will receive both an oral dose and a very small 'tracer' dose of the drug. They will need to stay in hospital for some parts of the study to collect samples and check their health. The study hopes to gather important information about this new treatment.

At a glance

Status

Not yet recruiting

Phase

PHASE1

Sponsor

AstraZeneca

Enrolment target

Start

17 Jan 2025

Estimated completion

08 Aug 2025

Neoplasm

What is this study about?

This study is looking at a new medicine called ceralasertib, which is being tested in people with certain types of cancer – specifically lung cancer (NSCLC), ovarian cancer, and endometrial cancer. The main purpose of the study is to understand exactly what happens to the drug inside your body. This includes how it's absorbed, how it travels through your system, and how your body gets rid of it. This information is really important because it helps doctors figure out the best way to give the medicine and learn more about how it might work.

To do this, some of the ceralasertib will have a tiny, safe amount of a special marker (like a tracking device) called carbon-14. This allows researchers to follow the drug's journey through your body by looking at samples like urine and faeces. You will receive the drug both as a pill and as a very small injection into a vein (known as an IV microdose). By comparing these, doctors can understand how much of the drug actually gets into your bloodstream when you take it by mouth.

You would stay in the study clinic or hospital for certain periods to allow the research team to collect these samples and closely monitor your health and how the drug is affecting you. Learning how your body handles ceralasertib is a vital step in developing new treatments that could potentially help people with these cancers in the future.

Key takeaways

Tests a new cancer drug called ceralasertib.
Aims to understand how the body uses and removes the drug.
For people with certain lung, ovarian, or endometrial cancers.
Involves hospital stays for monitoring and sample collection.
Possible access to the drug after the study if beneficial.

Who may be eligible?

To join this study, you need to be an adult aged 18 or older. You should be well enough to take part and able to swallow medicines by mouth. It’s also important that your body's organs, like your kidneys and liver, are working properly. You must be able and willing to follow the study rules and stay in the hospital for certain periods when required.

The study is specifically for people who have been diagnosed with certain types of lung cancer (NSCLC), ovarian cancer, or endometrial cancer. Your doctor will need to provide detailed information about your specific cancer diagnosis and any treatments you've had in the past.

There are also some reasons why you might not be able to join. For example, if you have certain other medical conditions or if your cancer has spread to your brain or spinal cord and is causing symptoms. Your medical team will carefully review all your health information to see if this study is suitable 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 NSCLC, ovarian, or endometrial cancer?
Are you generally well and able to swallow medicine?
Can you stay in the hospital for study periods?
Do your doctors think your organs (like kidneys, liver) are working well?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have two main parts, called Part A and Part B, with a rest period in between. For each part, you will stay at the study clinic or hospital. During these stays, you will be given the study drug ceralasertib. You will take it as a tablet, and also receive a tiny, special dose through a drip (IV) that helps researchers track it.

While at the clinic, the medical team will regularly collect samples like your urine and faeces to see how your body processes the drug. They will also take blood samples to measure drug levels and check your general health through regular safety assessments. After the main study parts, you will have a follow-up visit, which includes more health checks.

If the study doctors think it would be beneficial for you, you might be able to continue taking ceralasertib after the study parts are finished. This entire process, including the hospital stays, samples, and follow-up, will be clearly explained to you by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit of accessing an investigational new drug (ceralasertib) which could help your specific type of cancer, especially if other treatments haven't worked well. However, this is not guaranteed, and the drug is still being studied. There are potential risks, as any medicine can have side effects. These could range from mild to serious, and the study team will monitor you closely for any changes. You will receive detailed information about known side effects before you decide to take part. Remember, joining a clinical study is completely voluntary, and you have the right to withdraw at any time without affecting your medical care.

Locations (2)

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

Research Site
Verified postcode
Liverpool, United Kingdom
Research Site
Verified postcode
London, United Kingdom

Common questions

What is ceralasertib?

Ceralasertib is a new drug being tested to treat specific types of cancer, including lung (NSCLC), ovarian, and endometrial cancer.

Why will I stay in hospital?

You'll stay in hospital so the research team can carefully collect samples like urine and faeces, and monitor your health closely after you take the study drug.

What does a 'radiolabelled' drug mean?

This means a tiny, safe amount of a special tracking marker is added to the drug, allowing researchers to follow its path through your body.

Will I keep taking the drug after the study?

After the main study, if your doctors believe it could help you, you might be able to continue taking ceralasertib.

How long will the study take?

The study involves different parts with hospital stays and a follow-up visit. The study team will give you a detailed timeline.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

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