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

Study is designed to assess the safety and tolerability of ceralasertib at increasing doses in combination with other anti-cancer treatment in patients with advanced tumours

This is a new study looking at a medication called ceralasertib for people with advanced cancer. It's a very early-stage study, meaning it's the first time this drug is being given to people. The main goals are to check how safe ceralasertib is and to identify any side effects when used with other cancer treatments. Researchers will try different doses to find the safest and most effective amount. They'll also be carefully checking how the body handles the drug and looking for specific indicators (called 'biomarkers') that might show how well the treatment is working. This research is important for understanding new ways to fight cancer.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
AstraZeneca AB
Enrolment target
100
Start
04 Sep 2023

What is this study about?

This study is a very first step in testing a new cancer treatment called ceralasertib. When a new drug is first given to people (often called a 'Phase I' study), the main goal is to make sure it's safe and to see if there are any side effects. Researchers will be giving ceralasertib along with other standard cancer medicines to people who have advanced cancer.

The main thing they want to find out is how well people tolerate different amounts of ceralasertib. This means they will start with a small dose and gradually increase it, carefully watching for any unwanted reactions or health changes. They'll also be looking at how the drug moves through the body and if there are specific signs, like certain proteins (what doctors call 'biomarkers'), that can help understand how the treatment works.

This kind of study is really important because it helps scientists learn about new treatments in a safe and controlled way. The information gathered will help decide if ceralasertib can move on to larger studies to see if it's effective at treating cancer.

Key takeaways

  • Tests a new cancer drug called ceralasertib.
  • Focuses on safety and side effects in early-stage trials.
  • For adults with advanced solid tumours.
  • Combines ceralasertib with other cancer treatments.
  • Participation helps advance cancer research.

Who may be eligible?

This study is for adults, meaning you must be at least 18 years old. There's no upper age limit, so people of all adult ages can be considered. Both men and women are welcome to take part in this research.

To be eligible, you must have advanced cancer. This means your cancer has spread or is difficult to treat with standard therapies. The study is specifically looking for people with what are called 'advanced solid tumours'.

There may be other health requirements or things that would mean you couldn't join, which the study doctors will check carefully. For example, they will look at your heart health, particularly something called the 'QT interval', to make sure it's safe for you to take the study drugs. They will also look at your previous treatments and overall health.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with advanced solid cancer?
  3. Are you able to attend regular hospital or clinic appointments?
  4. Are you willing for doctors to monitor your heart and blood very closely?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the study drug, ceralasertib, along with other anti-cancer treatments. You'll need to attend regular appointments at the hospital or clinic. During these visits, doctors and nurses will monitor your health very closely. This will include blood tests to check how the drug is affecting your body and to look for specific markers that could tell us more about your cancer. You might also have heart checks, like an ECG, to monitor your heart rhythm.

The dosage of ceralasertib will likely be increased gradually under close supervision. The total length of your participation will depend on how you respond to the treatment and your overall health, but this is a clinical trial, so you will be monitored for an extended period, potentially several months or longer. Detailed schedules for visits and tests will be explained fully by the study team.

Potential risks and benefits

Potential benefits of joining this study include getting access to a new treatment before it's widely available, which might help your condition. You would also be contributing important information to medical science, which could help future cancer patients. As with any new medicine, there are potential risks and side effects that are not fully known yet, as this is an early-stage study. These could include heart changes (like an extended QT interval) or other side effects from the drugs. The study team will explain all known risks and monitor you very carefully for any new ones. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Common questions

What kind of cancer is this study for?

This study is for adults with advanced solid cancers, which means cancers that have developed into a solid mass and have spread or are difficult to treat.

What does 'Phase I' mean?

Phase I means this is one of the very first times this treatment is being given to people. The main aim is to check its safety and see how well people tolerate it.

Will this drug cure my cancer?

As this is an early-stage safety study, we don't know yet if this drug will cure cancer. The goal is to see if it's safe enough to continue testing for its effectiveness.

Will I get the new drug?

Yes, everyone in this particular study will receive the experimental drug ceralasertib, along with other anti-cancer treatments.

Who can join the study?

Adults aged 18 and over, both men and women, with advanced solid tumours, may be able to join. There are other health checks too.

How to find out more

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

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