Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Master Protocol Phase I/II Study to Investigate Biomarker‑Guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy for the Treatment of Participants with Advanced/Recurrent Ovarian Cancer (Ovarian Platform)

This research study is looking into a new treatment called Saruparib for women who have advanced or recurrent ovarian cancer. The study is split into two main parts: Phase I and Phase II. In Phase I, the doctors are mainly looking at the safety of Saruparib, checking for any side effects and finding the best dose. In Phase II, they will continue to monitor safety but will also look more closely at how well Saruparib works to shrink tumors or slow the cancer down. They will also explore if Saruparib works better when given alone or with other treatments. This study aims to find new and more effective ways to treat ovarian cancer.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

AstraZeneca AB

Enrolment target

Start

07 Jul 2025

Advanced/Recurrent Ovarian cancer

What is this study about?

This study is a research project focusing on a new medicine called Saruparib. It's designed for women who have ovarian cancer that has either spread or come back after previous treatment. The main goal is to understand how safe the new drug is and whether it can help shrink the cancer or stop it from growing further.

The study is set up in a special way called a 'Master Protocol.' This means it can test different treatment approaches with Saruparib, either by itself or in combination with other medicines, depending on specific markers found in a patient's cancer. This flexible approach helps researchers learn more efficiently about the best ways to use new drugs.

The researchers will be carefully monitoring participants by checking things like vital signs, blood tests, and scans. They will also look at how quickly the drug is absorbed and used by the body. This helps them understand how the drug works and find the most effective and safe way to use it for future treatments.

Key takeaways

This study is testing a new drug called Saruparib for ovarian cancer.
It's for women with advanced or recurrent ovarian cancer.
The main goals are to check the drug's safety and see if it helps shrink tumors.
Researchers will also explore if Saruparib works better alone or with other treatments.
It is an early-stage research study (Phase I/II) to learn about the new drug.

Who may be eligible?

This study is designed for women who are at least 18 years old.

To be considered for the study, you must have advanced or recurrent ovarian cancer. This means your cancer has either spread to other parts of your body or has returned after previous treatments.

The research team will need to check your medical history, current health, and specific characteristics of your cancer to make sure the study is a good fit for you. They will explain all the requirements in detail.

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.

I am female.
I am 18 years old or older.
I have been diagnosed with advanced or recurrent ovarian cancer.
My doctors have discussed my previous cancer treatments with me.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study drug, Saruparib. You will have regular visits to the hospital for checks, which may include physical exams, blood tests, heart rhythm checks (ECGs), and monitoring of your general well-being. The doctors will closely watch for any side effects and may adjust the drug dose if needed. We don't have the exact total duration or number of visits, as this can vary depending on the study phase and your response to treatment, but the study team will provide a detailed schedule. After treatment, there will likely be follow-up appointments to monitor your health.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit if Saruparib helps to control your cancer or improve your symptoms, though this is not guaranteed for everyone. However, all new medicines have potential risks, including side effects that could be mild or more serious. The research team will explain all known risks before you decide to join. Remember, you can choose to leave 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.

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Unverified
Italy
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Unverified
Spain

Common questions

What is Saruparib?

Saruparib is a new drug being tested to treat ovarian cancer. It's designed to target specific pathways involved in cancer growth.

What does 'advanced or recurrent ovarian cancer' mean?

Advanced means the cancer has spread beyond the original site, and recurrent means the cancer has come back after previous treatment.

Why is this study called a 'Master Protocol'?

It's a clever study design that allows researchers to test different ways of using Saruparib (alone or in combination) more efficiently, often adapting based on new findings from patients' specific cancer types.

Will I know if the drug is working?

The study team will regularly check for signs that the drug is affecting your cancer, such as changes in tumor size or blood test markers like CA125, and will discuss these results with you.

How long will I be in the study?

The exact length of time can vary based on the study phase and your individual response. The study team will give you a clear timeline if you are eligible.