Active not recruitingPHASE1INTERVENTIONAL

Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours

This is an early-stage study for people with advanced solid tumours. It's designed to understand how the body processes an experimental cancer drug called cediranib when it's taken alongside rifampicin, a widely used medication. Our bodies have ways of breaking down medicines, and sometimes one drug can affect how another drug is processed. By studying this, researchers hope to learn how to give cediranib most effectively and safely, particularly for patients who might need to take both medicines. This information is crucial for developing better cancer treatments in the future. Participants will receive both cediranib and rifampicin under close medical supervision.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

AstraZeneca

Enrolment target

Start

09 Sep 2008

Estimated completion

31 Dec 2026

Solid Tumors

What is this study about?

This study is a Phase 1 clinical trial, which means it's one of the first steps in testing a new treatment in people. The main goal is to understand how your body handles an experimental cancer drug called cediranib when it's used at the same time as another well-known medicine called rifampicin. Our bodies have natural ways of breaking down and getting rid of medicines. Sometimes, one medicine can speed up or slow down this process for another medicine. This is important to understand because it can affect how well a drug works and if it causes side effects.

Researchers want to see if rifampicin changes how much cediranib stays in your body and for how long. This is called 'pharmacokinetics' – simply how the body processes a drug. By understanding this, doctors can figure out the best and safest way to give cediranib to patients, especially if they need to take other essential medicines like rifampicin. This information will help them decide the right dose and timing for cediranib in real-world situations.

The findings from this study will be used to improve how cediranib is used in larger, later-stage studies and, hopefully, in future cancer treatments. It’s a vital step in making sure new cancer medicines are both effective and safe for patients.

Key takeaways

This study helps understand how two medicines work together in the body.
It's for people with advanced solid tumours where standard treatments haven't worked.
The main aim is to find the safest and most effective way to use cediranib.
Participants will take both an experimental cancer drug and a common infection medicine.
Your health will be closely watched throughout the study.
The findings will help improve future cancer treatments.

Who may be eligible?

To be considered for this study, you must have a type of advanced solid tumour that hasn't responded to standard treatments, or for which there are no effective standard treatments available. You must also be expected to live for at least eight more weeks and be generally well enough to participate in daily activities, meaning you can mostly look after yourself. All participants must be aged 18 or older.

There are also some reasons why you might not be able to join. For example, if your cancer has spread to your brain or the lining around your brain and is not stable, or if recent blood tests show certain levels outside the normal range. You also can't take part if you have serious digestive problems or if your bone marrow (which makes blood cells) isn't working as well as it should.

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.

Do I have a solid tumour that hasn't responded to other treatments?
Am I generally well and able to mostly look after myself?
Am I aged 18 or over?
Do I have stable cancer that hasn't seriously spread to my brain?
Are my recent blood test results within acceptable ranges?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given doses of both the experimental drug cediranib and the regular medicine rifampicin. You'll have regular hospital visits for blood tests and examinations to check how your body is handling the medicines and if there are any changes in your health. The doctors and nurses will closely monitor you for any side effects. The total duration of your participation in the study will depend on how you respond to the treatment and the study plan, but you will be kept informed every step of the way.

Potential risks and benefits

While participating, you might not directly benefit from this study, but the information gained will help future cancer patients by making new treatments safer and more effective. There are potential risks associated with taking any medication, including side effects from cediranib and rifampicin, which the medical team will explain in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (6)

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

Research Site
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Edmonton, Canada
Research Site
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Montreal, Canada
Research Site
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Dundee, United Kingdom
Research Site
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Glasgow, United Kingdom
Research Site
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London, United Kingdom
Research Site
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London, United Kingdom

Common questions

What is a 'solid tumour'?

A solid tumour is a mass of abnormal tissue that usually doesn't contain cysts or liquid areas. Most cancers are solid tumours.

What is cediranib?

Cediranib is a drug being tested to treat cancer. It's not yet widely available and is still in the experimental stage.

What is rifampicin?

Rifampicin is a medicine commonly used to treat bacterial infections, like tuberculosis. It's a standard and approved drug.

What does 'advanced cancer' mean?

Advanced cancer means the cancer has grown or spread from where it first started, and it might not be curable with standard treatments.

Will this study cure my cancer?

This early-stage study is primarily focused on understanding how drugs interact. While some patients might see benefits, the main goal is to gather information for developing future treatments, not to provide a cure in this phase.