Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1/2 Dose-Escalation and Dose-Expansion Study of ZN-c3 in Combination with Niraparib and ZN-c3 Monotherapy in Subjects with Platinum-resistant Ovarian Cancer.

This research study is looking into a new drug called azenosertib, also known as ZN-c3. It's for women who have ovarian cancer that has stopped responding to platinum-based chemotherapy, a common treatment. The study has two main parts. In one part, researchers are trying to find the best and safest dose of azenosertib when given by itself. In the other part, they are looking at azenosertib in combination with an existing drug called niraparib (Zejula). The main goals are to see how safe these treatments are, if they cause any side effects, and if they can shrink the cancer or stop it from growing. This is an early-stage study, meaning it's one of the first times these treatments are being tested in people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

K-Group Beta Inc.

Enrolment target

150

Start

27 Nov 2024

Platinum-Resistant Ovarian Cance

What is this study about?

This study is for women who have ovarian cancer that has become resistant to standard chemotherapy treatments, specifically platinum-based drugs. When cancer stops responding to these treatments, doctors look for new ways to help. This study is exploring a new drug called azenosertib (you might also see it called ZN-c3) to see if it can be an effective option.

The study has a few aims. Firstly, it wants to find the safest and most effective dose of azenosertib when given on its own. This helps doctors know how much medicine to give to get the best results with the fewest side effects. Secondly, the study is also looking at giving azenosertib alongside an existing ovarian cancer drug called niraparib (brand name Zejula). Combining treatments can sometimes be more effective than a single drug, and the researchers want to see if this combination works well and is safe.

The main things the researchers will be watching are how well the treatments are tolerated, meaning what side effects people experience, and how severe they are. They will also be very carefully checking to see if the treatments help shrink the cancer or stop it from growing for a period of time. This information is key to understanding if these new approaches could become future treatments for ovarian cancer.

Key takeaways

This study is for women with ovarian cancer resistant to standard platinum-based chemotherapy.
It tests a new drug, azenosertib (ZN-c3), either alone or with niraparib (Zejula).
The main goals are to find a safe dose and see how well the treatments work against the cancer.
Participation involves regular clinic visits, blood tests, and scans.
You will be closely monitored for any side effects and your general well-being.
This is an early-stage study, exploring new options for a challenging cancer.

Who may be eligible?

This study is looking for women aged 18 or older who have been diagnosed with ovarian cancer. To be eligible, your cancer must have previously been treated with chemotherapy containing platinum-based drugs, and it must now be considered 'platinum-resistant'. This means your cancer has either grown or returned within six months of your last platinum-based treatment.

There will be other specific health requirements that your doctor will check to make sure participating in the study is safe for you. These might include certain blood test results, heart health, and how well your kidneys and liver are working. You will also need to be well enough to take part in the study and attend all appointments.

It's important to have a detailed discussion with your cancer specialist or the study team. They will go through all the specific criteria with you to determine if this study is a suitable option for your unique situation.

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 female and aged 18 or older?
Do you have ovarian cancer?
Has your ovarian cancer been treated with platinum-based chemotherapy before?
Has your cancer started to grow again or returned within six months of your last platinum-based treatment?
Are you generally well enough to participate in a clinical study?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, you would first go through a screening period to make sure you meet all the health requirements. Once accepted, you would receive the study medication, either azenosertib on its own or azenosertib with niraparib, usually in cycles. These medications are film-coated tablets you would take.

Throughout the study, you would have regular visits to the clinic. These visits would involve various assessments, including physical examinations, blood tests to check how your body is reacting to the drugs, and scans (like CT or MRI) to see how the cancer is responding. These checks help the doctors monitor your health, adjust doses if needed, and track the effectiveness of the treatment.

The study will also involve closely monitoring any side effects you might experience and asking about your quality of life during treatment. The total duration of your participation would depend on how your cancer responds to the treatment and how you tolerate the medication, but monitoring would continue for some time after you stop taking the study drugs.

Potential risks and benefits

Participating in a clinical trial like this may offer potential benefits, such as access to a new treatment that isn't widely available yet, which might help control your cancer. You would also receive very close medical attention and monitoring from a dedicated research team. However, there are also potential risks, including side effects from the study drugs, which can vary from mild to severe, and the treatment might not be effective for your specific cancer. As with any clinical trial, there's no guarantee of benefit. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

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

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Unverified
France

Common questions

What is 'platinum-resistant ovarian cancer'?

This means your ovarian cancer has either grown or come back within six months of finishing chemotherapy that included 'platinum'-type drugs, such as cisplatin or carboplatin.

What is azenosertib (ZN-c3) and niraparib?

Azenosertib is a new experimental drug being tested. Niraparib (Zejula) is an approved drug already used to treat some ovarian cancers. This study explores them alone or together.

What does 'Phase 1/2' mean?

This is an early stage clinical study. Phase 1 focuses on finding the safest dose and understanding side effects. Phase 2 then looks more closely at how well the treatment works at that chosen dose.

How will doctors know if the treatment is working?

Doctors will use regular scans and tests to see if your cancer shrinks or stops growing. They will also monitor your overall health and any symptoms you have.

Will I have to pay to be part of the trial?

No, you will not have to pay for the study drugs or any of the medical care related to the trial. However, you would need to cover your travel costs to and from the study site, unless otherwise specified by the trial centre.