Active not recruitingPHASE1INTERVENTIONAL

Phase I Comparative Bioavailability Study

This study is a Phase 1 clinical trial designed to compare two different ways of taking the same new cancer medicine, called AZD2281. The main goal is to see how well the body absorbs and uses each version of the drug. It involves patients with advanced solid tumors, which are cancers that have grown or spread and haven't responded well to usual treatments or for which there are no standard treatments available. By understanding how the body processes these different forms of the medicine, researchers can work out the best and most effective way to give AZD2281 to patients in the future. This is an early-stage study to gather important information about this potential new treatment.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

AstraZeneca

Enrolment target

197

Start

27 Oct 2008

Estimated completion

31 Mar 2027

Solid Tumors

What is this study about?

This study is an early-stage clinical trial, called a Phase 1 study. Its main purpose is to learn more about a new medicine called AZD2281, which is being tested for people with advanced solid tumors, a type of cancer that affects solid organs like the breast, lung, or bowel. Sometimes, cancers become advanced when they grow or spread, or when standard treatments no longer work well.

The study aims to compare two slightly different forms of this medicine, both given by mouth. Researchers want to understand how the body absorbs and uses each form. This is important because the way a medicine is absorbed can affect how well it works and any side effects it might cause. By comparing these two forms, doctors can figure out which one might be better or more consistent for future patients.

Taking part in this study helps doctors gather crucial information about new treatments. This kind of research is vital for developing better ways to fight cancer in the future. It helps ensure that when new medicines are eventually approved, they are given in the most effective and safest way possible.

Key takeaways

It's an early-stage study (Phase 1) looking at a new cancer medicine.
Compares two ways of taking AZD2281 for advanced solid tumors.
Main goal is to understand how the body absorbs and uses the drug.
For adults whose cancer hasn't responded to standard treatments.
Helps researchers find the best way to give the medicine in the future.

Who may be eligible?

This study is looking for adults aged 18 or older who have advanced solid tumors. Your cancer should have either not responded to usual treatments, or there shouldn't be any standard treatments currently available for your type of cancer. It's important that your organs, like your kidneys and liver, and your blood are working well.

For women, you must not be able to become pregnant, or you must have a negative pregnancy test shortly before starting. This is to ensure the safety of any unborn child. A few specific groups of patients can't take part, for example, if you've recently had major surgery or are receiving certain other cancer treatments.

There are also some very specific rules for one group of patients (Group 8) which your doctor will be able to explain, particularly about previous platinum-based chemotherapy. If you have active brain tumors causing symptoms or certain blood conditions, you would also not be able to join this study.

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 tumor that hasn't responded to usual treatments, or for which there are no standard treatments?
Is your liver, kidneys, and blood generally healthy?
If you are a woman, are you unable to become pregnant or have a negative pregnancy test?
Have you recently had major surgery or received certain other cancer treatments? (This might affect eligibility).
Do you have active, symptomatic brain tumours or certain blood disorders? (These would likely exclude you).

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study medicine, AZD2281, in two different forms over a period of time, though you won't know which form you're receiving at any given time. You will have regular visits to the clinic for medical checks, blood tests, and to answer questions about how you're feeling. This is to monitor your health and see how you respond to the treatment.

These visits will likely involve checking your vital signs, taking blood samples, and perhaps urine samples. You'll also be asked about any side effects you might be experiencing. The total duration of your participation in the study, including the treatment period and follow-up, will be explained to you by the study team, but it will involve several visits over a period of weeks or months.

Potential risks and benefits

Taking part in a clinical trial may offer the potential benefit of accessing a new treatment like AZD2281 before it's widely available. While this medicine is being tested to see if it can help, there's no guarantee it will work for you. There are always potential risks, including side effects from the medication. These will be fully explained to you before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (10)

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

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Randwick, Australia
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Leuven, Belgium
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Bellinzona, Switzerland
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Edinburgh, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Northwood, United Kingdom
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Oxford, United Kingdom
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Sutton, United Kingdom

Common questions

What is a Phase 1 study?

Phase 1 studies are early steps in developing new medicines. They primarily check if a new drug is safe and how the body handles it, rather than how well it treats the disease.

What does 'advanced solid tumor' mean?

It means the cancer has grown or spread, or treatments you've tried before haven't worked or are no longer an option.

Will I know which version of the medicine I'm getting?

No, this study is 'blinded', meaning you won't know which of the two forms of AZD2281 you are receiving at any given time during the trial.

What are 'adequate organ and bone marrow function'?

This means your kidneys, liver, and the blood-making parts of your bone marrow are generally healthy enough to safely receive the study medicine.

Can I still get other cancer treatments while on this study?

Generally, no, you can't be on most other cancer treatments. However, some exceptions like certain bone medications (biphosphonates) or steroids are usually allowed.