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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A trial to learn how saruparib works and how safe it is in the bodies of adults with advanced solid tumors

This research study is for adults who have advanced solid cancers that have spread or cannot be removed. It's looking at a new medicine called saruparib. The main goals of the study are to understand how this new medicine behaves in the body and to find out if it is safe to use. This is called a Phase 1 study, which means it's one of the first times the medicine is being tested in people. Because it's an early-stage trial, there isn't much information yet about whether it will help cancer, but it's an important step in developing new treatments. All adults aged 18 and over, both men and women, might be able to take part.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
AstraZeneca AB
Enrolment target
33
Start
22 May 2025

What is this study about?

This study is a research project designed to learn more about a new medicine called saruparib. It's being offered to adults who have a type of advanced cancer that affects solid organs or tissues, rather than blood. These cancers are sometimes called 'solid tumours' and `advanced` means they may have spread or are difficult to treat with standard methods.

The main purpose of this study is to answer two important questions: Firstly, how does saruparib move through and get processed by the body? This helps doctors understand the right amount of medicine to give. Secondly, is saruparib safe for people to take? This involves watching closely for any side effects or unwanted reactions.

This is an early stage of research, known as a 'Phase 1' study. At this point, the focus is on safety and understanding the drug's basic actions, rather than how well it treats cancer. Studies like this are vital steps in developing new medicines that might help people with cancer in the future.

Key takeaways

  • Study is for adults with advanced solid cancers.
  • Investigating a new medicine called saruparib.
  • Focus is on safety and how the medicine works in the body.
  • This is an early-stage (Phase 1) clinical trial.
  • Open to all adults aged 18 and over, both men and women.

Who may be eligible?

To be able to join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

You would also need to have a type of advanced cancer that affects solid organs or tissues. This means cancers that are not blood cancers and have progressed or spread.

The doctors running the study will check other specific medical details to make sure the study is a good and safe fit for you. These checks are important to protect your 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. Do you have an advanced cancer (not a blood cancer) that affects a solid organ or tissue?
  3. Are you willing to have regular medical checks and tests?
  4. Are you comfortable with receiving a new, untested medicine?
Answer every question to see your result.

What does participation involve?

We don't have all the details about what taking part would involve yet. However, in studies like this, you typically would have regular visits to the clinic for medical checks, blood tests, and to receive the study medicine, saruparib. Doctors and nurses would monitor your health closely and ask about any side effects you might experience. There would also be follow-up appointments after you stop taking the medicine. The total length of your involvement in the study would be explained in full by the study team.

Potential risks and benefits

Participating in a study like this could potentially help future patients by providing important information about a new treatment, even if it doesn't directly benefit you. However, there are potential risks, as saruparib is a new medicine and its full side effects are not yet known. Like all medicines, it may cause unwanted reactions, some of which could be serious. You will be told about all known risks before you decide to take part, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

Common questions

What kind of cancer is this study for?

This study is for adults with advanced cancers that affect solid organs or tissues, not blood cancers.

What is 'saruparib'?

Saruparib is a new medicine being tested in this study to see how it works and if it's safe.

What does 'Phase 1' mean?

Phase 1 means it's an early stage of testing where doctors are mainly looking at how safe the medicine is and how it acts in the body.

Will this medicine cure my cancer?

The main goal of this early study is to understand safety and how the drug works, not to cure cancer. Any benefit in treating cancer is not the primary focus at this stage.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without having to give a reason, and it won't affect your future medical care.

How to find out more

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

Discussion

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